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Background: The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes. Methods: A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related to MitraClip implantation from October 2013 to September 2023. Duplicate reports and records from unrelated sources were excluded. The Cochran-Armitage test was performed to evaluate trends in the proportion of fatal events over time. Results: During the 10-year period following FDA approval, the MAUDE database recorded a total of 927 death reports and 9,211 injury reports associated with MitraClip. After excluding duplicates and irrelevant reports, 592 death cases were analyzed. The most commonly reported complications were MR (26.69%), tissue damage (24.16%), and hypotension (22.13%). The most frequent device-related issues were incomplete coaptation (14.70%), difficulty removing the divice (6.42%), and failure to adhere or bond/positioning failure(4.90%). Notably, 76.94% of deaths occurred within one year of implantation. The proportion of fatal events demonstrated a gradual decline, from 15.9% in 2014–2015 to 3.5% in 2020–2021 (p < 0.0001). Conclusions: This analysis of the MAUDE database indicates a gradual decline in the proportion of fatal events associated with MitraClip implantation, which may be attributed to growing operator experience and advancements in device design. Nonetheless, persistent focus is required on managing complications and addressing potential risks to further enhance device performance and optimize its clinical utility. [ABSTRACT FROM AUTHOR]

Background: MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there have been several Field Safety Notices issued, including a worldwide product recall due to actuator endcap separation. We aimed to review adverse events reported to the Food and Drug Administration (FDA) regarding MAGEC rods, focusing on MAGEC X. Methods: Reports submitted to the Manufacturer and User Facility Device Experience database in relation to MAGEC devices were accessed and analysed using R Statistical Software. Exclusion criteria included duplicate and literature review reports (n = 54). Free-text data were analysed using inductive content analysis. Results: 1016 adverse events were reported to 11/30/2023. 99.0% (1006) were submitted by the manufacturer. Reports primarily arose from the UK (465, 45.8%) or US (421, 41.4%). From free-text data the most frequent adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180). Rod fracture (n = 48) was not significantly associated with rod diameter (≤ 5.0 mm or > 5.0 mm), p = 0.736. 234 reports referenced MAGEC X devices; actuator endcap separation was identified in 41.9% (99). Other events include failure of distraction (63), surface damage (31), and rod fracture (15). On 06/30/2020 MAGEC X2 received FDA approval. Twenty reports reference devices manufactured after this date, seven describe distraction mechanism failure; notably there are no reports of endcap separation. Conclusion: These data represent the largest series of adverse events reported for MAGEC rods, including significant new data regarding MAGEC X. As well as endcap separation, failure of distraction, surface damage, and rod fracture were reported. [ABSTRACT FROM AUTHOR]

Abstract Background The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes. Methods A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related to MitraClip implantation from October 2013 to September 2023. Duplicate reports and records from unrelated sources were excluded. The Cochran-Armitage test was performed to evaluate trends in the proportion of fatal events over time. Results During the 10-year period following FDA approval, the MAUDE database recorded a total of 927 death reports and 9,211 injury reports associated with MitraClip. After excluding duplicates and irrelevant reports, 592 death cases were analyzed. The most commonly reported complications were MR (26.69%), tissue damage (24.16%), and hypotension (22.13%). The most frequent device-related issues were incomplete coaptation (14.70%), difficulty removing the divice (6.42%), and failure to adhere or bond/positioning failure(4.90%). Notably, 76.94% of deaths occurred within one year of implantation. The proportion of fatal events demonstrated a gradual decline, from 15.9% in 2014–2015 to 3.5% in 2020–2021 (p

Objective: The aim of this study was to assess the real-world safety profile of medical devices used in focal prostate cancer treatment utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was searched for reports on high-intensity focused ultrasound (HIFU), cryoablation, laser ablation, and irreversible electroporation (IRE) devices used in prostate cancer treatment from 1993 to 2023. Adverse events were identified and categorized. Results: We identified 175 reports for HIFU, 1362 for cryoablation, 615 for laser ablation, and 135 for IRE devices, with 28, 284, 126, and 2 respective reports, directly related to prostate cancer treatment. The aggregated data revealed the majority of complications were minor, with 82.5% (n = 363 out of 440 total complications) classified as Clavien-Dindo grade 1 or 2. Common minor complications included erectile dysfunction and urinary retention. Severe complications such as rectal fistulas were noted in HIFU and IRE treatments, along with singular mortality due to pulmonary embolism in cryoablation. Conclusions: Our analyses from MAUDE reveal that devices used in focal therapy for prostate cancer are predominantly associated with minor complications, underscoring their overall real-world safety profile. However, the occurrence of severe adverse events emphasizes the critical importance of rigorous patient selection and meticulous procedural planning. These findings provide valuable insights into the safety profile of focal therapy devices and contribute to the growing body of evidence on their use in prostate cancer treatment. [ABSTRACT FROM AUTHOR]

Reaction Systems (RSs) are a computational framework inspired by biochemical systems, where entities produced by reactions can enable or inhibit other reactions. RSs interact with the environment through a sequence of sets of entities called the context. In this work, we introduce ccReact, a novel interaction language for implementing and verifying RSs. ccReact extends the classical RS model by allowing the specification of recursive, nondeterministic, and conditional context sequences, thus enhancing the interactive capabilities of the models. We provide a rewriting logic (RL) semantics for ccReact, making it executable in the Maude system. We prove that our RL embedding is sound and complete, thereby offering a robust tool for analyzing RSs. Our methods enable various formal analysis techniques for RSs, including simulation of RSs interacting with ccReact processes, verification of reachability properties, model checking of temporal (LTL and CTL) formulas, and exploring the system evolution through a graphical tool to better understand its behavior. We apply our methods to analyze RSs from different domains, including computer science and biological systems. Notably, we examine a complex breast cancer case study, demonstrating that our analysis can suggest improvements to the administration of monoclonal antibody therapeutic treatments in certain scenarios. [ABSTRACT FROM AUTHOR]

Background: Interspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs. Study Design: This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database. Methods: The database was queried from its inception to November 2022 for reports associated with "Prosthesis, Spinous Process Spacer/Plate." Entries were categorized by event type, patient impact, and interventions. Results: A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, n = 374) and fractures (2.2%, n = 21). The most common postoperative events were persistent pain (26.6%, n = 251), implant migration (19.1%, n = 180), and fracture (6.8%, n = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, n = 460). The need for revision surgery was common in patients who experienced fracture (47.1%), implant migration (84.5%), infection (76.7%), and neurological complications (76.9%). Implant migration, fracture, and implant malfunction, 3 complications that are unique to decompression with an IPD as compared with traditional laminectomy, accounted for 45.9% of revisions (211/460), and revision was required in 33.0% of cases where 1 of these complications was reported (211/640). Implant malfunction made up 21.2% of Coflex complications, 47.3% of Superion complications, and 5.2% of X-Stop complications. Conclusions: The most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants. Clinical Relevance: Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery. [ABSTRACT FROM AUTHOR]

Study design. Retrospective database review. Objective. The aim of this study was to analyze revisions of CDAs reported to the MAUDE database. Summary of Background Data. Cervical disk arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs. Methods. The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared. Results. A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify. Conclusions. The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification, varying in their rerelvance depending on the CDA. [ABSTRACT FROM AUTHOR]

Introduction: The QDOT MICROTM Ablation Catheter is a next‐generation ablation catheter that allows for high‐power ablation up to 90 watts. Methods: We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter. Results: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter‐related issues and 154 (51%) clinical complications. Among the catheter‐related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade). Conclusion: As high‐power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter‐related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy. [ABSTRACT FROM AUTHOR]

Introduction: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Methods: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. Results: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). Conclusion: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations. [ABSTRACT FROM AUTHOR]

Ambu® aScope™ is a disposable flexible videoscope used for a wide range of medical procedures. However, adverse events associated with this device can occur. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was explored for patient‐related adverse events associated with Ambu® aScope™ use between January 1, 2000 and December 15, 2023. Search terms included "Ambu" and "Ascope." Thirty unique adverse events were identified. Twenty‐one of the events were associated with patient injury, and 9 with device malfunction. Eight patient‐reported problems were documented as foreign bodies, 3 events as airway obstruction, desaturation, or hypoxic events, and 1 event as anxiety/cardiac arrest. The remaining 18 reported insufficient information other than associated with patient injury. We found that Ambu® aScope™ flexible nasolaryngoscopes and bronchoscopes are a common and effective tool for airway evaluations that may infrequently serve as a rare form of foreign body with potentially life‐threatening consequences. [ABSTRACT FROM AUTHOR]

The manufacturer and user facility device experience database (MAUDE) is a national database of adverse events of medical devices managed by the FDA. As a medical device material, breast implants have a large number of adverse events reported in the MAUDE database. Retrieve and download all adverse events from November 1, 2020 to October 31, 2023, It mainly includes common local complications and non-specific breast implant illness (BII). At present, the causal relationship between the occurrence of BII and breast prosthesis is inconclusive in academia, and a better understanding of BII may allow beauty seekers to further consider whether the benefits of breast implantation outweigh the risks. Here is to make a review of the the risks and adverse reactions of breast prosthesis implantation. [ABSTRACT FROM AUTHOR]

This article presents a symbolic approach to model checking quantum circuits using a set of laws from quantum mechanics and basic matrix operations with Dirac notation. We use Maude, a high-level specification/programming language based on rewriting logic, to implement our symbolic approach. As case studies, we use the approach to formally specify several quantum communication protocols in the early work of quantum communication and formally verify their correctness: Superdense Coding, Quantum Teleportation, Quantum Secret Sharing, Entanglement Swapping, Quantum Gate Teleportation, Two Mirror-image Teleportation, and Quantum Network Coding. We demonstrate that our approach/implementation can be a first step toward a general framework to formally specify and verify quantum circuits in Maude. The proposed way to formally specify a quantum circuit makes it possible to describe the quantum circuit in Maude such that the formal specification can be regarded as a series of quantum gate/measurement applications. Once a quantum circuit has been formally specified in the proposed way together with an initial state and a desired property expressed in linear temporal logic (LTL), the proposed model checking technique utilizes a builtin Maude LTL model checker to automatically conduct formal verification that the quantum circuit enjoys the property starting from the initial state. [ABSTRACT FROM AUTHOR]

Purpose: The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. Methods: The Manufacturer and User Facility Device Experience database was queried for "Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift" from 2018 through 2021. A complication classification system (Level I–IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as "device related" and "non-device related." Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. Results: A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II–IV (clinically significant). Aquablation (p < 0.017) and Water Vapor Thermal Therapy (p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. Conclusions: Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions. [ABSTRACT FROM AUTHOR]

The increasing use of MAUDE reports in patient safety research highlights the importance of understanding the processing and dissemination of open-access MAUDE data. However, the absence of a structured data pipeline undermines the reproducibility and transparency of studies relying on MAUDE data. In response, we conducted a comprehensive analysis of a recent study on endoscopic clips, assessing methodologies and results. We advocate for implementing an extract, transform, and load (ETL) pipeline, utilizing openFDA and integrating keyword search strategies and data visualization techniques. This approach aims to enhance the quality of MAUDE-based studies, ensuring their reproducibility and transparency. Moreover, ETL serves as a cornerstone in data engineering, enabling real-time data management and quality assurance, thus promoting the sustainability and collaboration of MAUDE-based patient safety research. [ABSTRACT FROM AUTHOR]

State Machine Graphical Animation (called SMGA) is a visualization tool that assists formal methods experts in conjecturing characteristics of a protocol/system. The characteristics guessed by using the tool can be used as lemma candidates to theorem prove that the protocol/system satisfies its desired properties. Because previous work has shown that interaction in SMGA is one promising factor to foster assistance, in this paper, we revise SMGA equipping it with various interactive features in order to help human users in conjecturing lemmas. Moreover, we integrate SMGA and Maude, a declarative language and high-performance tool, so that the revised version of SMGA (called r-SMGA) can use some powerful features of Maude, such as parsing associative-commutative binary operators as well as context-free grammars, reachability analysis, and model checking. We conduct a case study with the Suzuki-Kasami protocol to demonstrate the usefulness of these new features. In the case study, some characteristics are conjectured and confirmed with these features. Based on the guessed characteristics and assistance of r-SMGA, we successfully prove that the protocol enjoys the mutual exclusion property. Finally, we propose guidelines that can help users to conjecture characteristics using r-SMGA. Our result shows that the graphical animation approach is useful for lemma conjecture in theorem proving. The formal verification is a part of the case study. [ABSTRACT FROM AUTHOR]

The MAUDE database is a valuable public resource for understanding malfunctions and adverse events related to medical devices and health IT. However, its extensive data and complex structure pose challenges. To overcome this, we have developed an automated analytical pipeline using GPT-4, a cutting-edge large language model. This pipeline is intended to efficiently extract, categorize, and visualize safety events with minimal human annotation. In our analysis of 4,459 colonoscopy reports from MAUDE (2011-2021), the events were categorized into operational, human factor, and device-related. Ishikawa diagrams visualized a subset stored in a vector database for easy retrieval and comparison through a similarity search. This innovative approach streamlines access to vital safety insights, reducing the workload on human annotators, and holds promise to enhance the utility of the MAUDE database. [ABSTRACT FROM AUTHOR]

The use of the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) to analyze adverse events linked to medical devices has grown in recent years. MAUDE facilitates post‐market surveillance, contributing to the assessment of device performance and the identification of potential safety concerns. The database is instrumental not only for mandatory reporters such as manufacturers and healthcare facilities but also offers a platform for voluntary submissions from clinicians and patients, thus widening the scope of data collection. While the database offers valuable data, there are important limitations that must be understood in order to encourage appropriate interpretation of findings. This commentary highlights the major advantages and disadvantages of the MAUDE database, as well as describes possible areas for improvement in adverse event reporting. [ABSTRACT FROM AUTHOR]

BackgroundNasopharyngeal swab testing, which has greatly increased in utilization due to the COVID-19 pandemic, is generally safe and well-tolerated, although it may be rarely associated with adverse events.MethodsPublicly reported adverse events associated with nasopharyngeal COVID-19 testing within the Manufacturer and User Facility Device Experience (MAUDE) database and the published literature were queried.ResultsA total of 129 adverse events were reported, including 66 from the MAUDE database and 63 from literature review. The most common complications were swab fracture resulting in retained foreign body (47%), followed by epistaxis (17%), and headache (11%). Seven (12%) of the reported retained foreign body cases required removal under general anesthesia, while 1 (5%) of the epistaxis cases required surgical intervention. The most serious adverse event was meningitis following cerebrospinal fluid leak.ConclusionsPatients and healthcare providers should be aware of the potential risks associated with testing, with attention to ensuring proper technique, and be prepared to recognize and manage adverse events.

This paper presents a concrete and a symbolic rewriting logic semantics for parametric time Petri nets with inhibitor arcs (PITPNs), a flexible model of timed systems where parameters are allowed in firing bounds. We prove that our semantics is bisimilar to the "standard" semantics of PITPNs. This allows us to use the rewriting logic tool Maude, combined with SMT solving, to provide sound and complete formal analyses for PITPNs. We develop and implement a new general folding approach for symbolic reachability, so that Maude-with-SMT reachability analysis terminates whenever the parametric state-class graph of the PITPN is finite. Our work opens up the possibility of using the many formal analysis capabilities of Maude—including full LTL model checking, analysis with user-defined execution strategies, and even statistical model checking—for such nets. We illustrate this by explaining how almost all formal analysis and parameter synthesis methods supported by the state-of-the-art PITPN tool Roméo can be performed using Maude with SMT. In addition, we also support analysis and parameter synthesis from parametric initial markings, as well as full LTL model checking and analysis with user-defined execution strategies. Experiments show that our methods outperform Roméo in many cases. [ABSTRACT FROM AUTHOR]

Reaction Systems (RSs) are a successful computational framework for modeling systems inspired by biochemistry. An RS defines a set of rules (reactions) over a finite set of entities (e.g., molecules, proteins, genes, etc.). A computation in this system is performed by rewriting a finite set of entities (a computation state) using all the enabled reactions in the RS, thereby producing a new set of entities (a new computation state). The number of entities in the reactions and in the computation states can be large, making the analysis of RS behavior difficult without a proper automated support. In this paper, we use the Maude language—a programming language based on rewriting logic—to define a formal executable semantics for RSs, which can be used to precisely simulate the system behavior as well as to perform reachability analysis over the system computation space. Then, by enriching the proposed semantics, we formalize a forward slicer algorithm for RSs that allows us to observe the evolution of the system on both the initial input and a fragment of it (the slicing criterion), thus facilitating the detection of forward causality and influence relations due to the absence/presence of some entities in the slicing criterion. The pursued approach is illustrated by a biological reaction system that models a gene regulation network for controlling the process of differentiation of T helper lymphocytes. [ABSTRACT FROM AUTHOR]

Objective: Tracheotomy is one of the most common procedures. Although tracheostomy complications have been extensively studied, literature related to device complications is scarce. The objective of this study is to describe complications associated with tracheostomies utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. Study Design: Retrospective cross‐sectional study. Setting: The US Food and Drug Administration's (FDA) MAUDE database (2015‐2020). Methods: The FDA's MAUDE database was queried for all reports on adverse events related to tracheostomy from January 1, 2015 to December 31, 2020. Results: A total of 3086 adverse events related to open tracheostomy and 52 related to percutaneous tracheostomy were identified. For open tracheostomy, 2872 (93%), were related to device malfunction, and 214 (7%) consisted of patient‐related factors. The most frequently reported device‐related adverse event was cuff malfunction, with 1834 (59%) reported events, which includes cuff deflation, pilot balloon malfunction, and cuff inflation line malfunction. The most frequently reported patient‐related adverse events were tracheostomy tube obstruction with 67 events (2%). For percutaneous tracheostomy, 38 (73%) events were related to device malfunction, and 14 (27%) were related to patient injury. The most frequently reported adverse events were cuff malfunction (29%), safety ridge malfunction (17%), and bleeding (10%). Conclusion: The MAUDE database is a useful tool that can be utilized to complement existing literature in identifying common and rare adverse events associated with tracheostomy device‐related failures, which are mostly reliant on isolated, published case reports. [ABSTRACT FROM AUTHOR]

Objective: To characterize adverse events, provide a safety profile, and understand patient outcomes after complications arising from LigaSure and Harmonic use in the head and neck region. Methods: Retrospective analysis of adverse events from the Manufacturer and User Facility Device Experience (MAUDE) between January 2013 and 2023. Results: A total of 158 LigaSure and 159 Harmonic events were extracted. There were significantly more reports of Harmonic device overheating (6.9% vs. 0.6%, p = 0.003) and spontaneous self‐activation (4.4% vs. 0%, p = 0.032). Although intra‐operative and post‐operative complications were similar among both groups, there were significantly more intra‐operative bleeding events for LigaSure as compared to Harmonic (8.2% vs. 0.0%, p = 0.001). Conclusion: Understanding technical complications and adverse events attributable to LigaSure and Harmonic devices enables the development of clinically relevant risk mitigation strategies. Surgeons should avoid improper use by remaining vigilant of device functionality and temperature changes. [ABSTRACT FROM AUTHOR]

Introduction: Phototherapy and photodynamic therapy (PDT) are ultraviolet light (UV) based therapies for patients with skin diseases, and are sometimes associated with potential adverse events (AE)s, including erythema, pain, pruritus, burns, and photoaging. Methods: We investigated UV phototherapy and PDT safety using the United States (US) Food and Drug Administration’s (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database, including medical device reports (MDR)s informed by voluntary and obligatory reporters since 1991, was searched for AEs associated with UV phototherapy and PDT 1/1/91–3/1/23. Results: There were 59 UV phototherapy and 33 PDT related MDRs. Burns were the most common AE type for both phototherapy and PDT. The majority of phototherapy AEs occurred during 2021 (52.3%), and were significantly more likely to occur at home than in the clinic. Overall, 76.1% of MDRs associated with home light boxes were prescribed by online retailers, most of the MDRs (59.3%) mentioned that it is prohibited to sell phototherapy devices not prescribed by physicians, and only 8.5% noted poorly written home light box instructions. Discussion: The COVID-19 pandemic prohibited in-person light treatments, and social distancing requirements may have resulted in increased frequency of home-based light treatments. Hence, while at home treatment may be easier and more accessible, in-office physician supervised UV treatments are associated with less frequent AEs. Moreover, some phototherapy MDRs reported poorly written instructions accompanying the home light box, and some PDT MDRs documented patients receiving inadequate education regarding the procedure. With the rise of at-home treatment options and the ease of obtaining devices on the internet, it is physicians’ duty to advise patients against self-treating with home light boxes without prescribed treatment regimens and educate patients that are considering home phototherapy to ensure safer patient experiences. [ABSTRACT FROM AUTHOR]

In previous work, summarized in this paper, we proposed an operation of parallel composition for rewriting-logic theories, allowing compositional specification of systems and reusability of components. The present paper focuses on compositional verification. We show how the assume/guarantee technique can be transposed to our setting, by giving appropriate definitions of satisfaction based on transition structures and path semantics. We also show that simulation and equational abstraction can be done componentwise. Appropriate concepts of fairness and deadlock for our composition operation are discussed, as they affect satisfaction of temporal formulas. We keep in parallel a distributed and a global view of composed systems. We show that these views are equivalent and interchangeable, which may help our intuition and also has practical uses as, for example, it allows global-style verification of a modularly specified system. Under consideration in Theory and Practice of Logic Programming (TPLP). [ABSTRACT FROM AUTHOR]

Currently, Model-Driven Engineering (MDE) plays a key role in the software development process as it aims to handle their increasing complexity and focuses on the automatic generation of code and/or specifications from system models. This paper presents a very useful tool for the automatic generation of Maude specifications from both Petri net PNML (Petri Net Markup Language) descriptions or incidence matrices. At the end of this paper, a simple but complete Petri net example will be presented to demonstrate the usefulness of the developed tool.