Adverse events of the over the scope endoscopic clips and cutters: A MAUDE database analysis

Abstract

Background and aims:The OVESCO® clip system, including the Over-The-Scope Clip (OTSC) and Full-Thickness Resection Device (FTRD), has demonstrated efficacy in managing various gastrointestinal pathologies. However, real-world data on device malfunctions and patient complications are limited. This study aimed to analyze adverse events associated with OVESCO® clips and cutters reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

Methods:The MAUDE database was searched for reports related to OVESCO® clips and cutters from January 1, 2007, to August 30, 2024. Event date, device type and model, manufacturer, event type, device problem, and patient complications were extracted. Descriptive statistics were used to summarize the findings.

Results:Forty-two reports were identified, with 41 involving OVESCO® clips and one involving an OVESCO® cutter. The most common device problem for OVESCO® clips was failure to deploy (61.0%), followed by unintended deployment or misfiring (17.1%). Gastrointestinal perforation was the most frequently reported patient complication (60%). The OVESCO® cutter report described device component breakage and foreign body retention. No clear trends in adverse event reporting were observed over the study period.

Conclusion:OVESCO® clips and cutters are associated with potential device malfunctions and patient complications, particularly gastrointestinal perforation. The findings highlight the need for careful patient selection, meticulous technique, and close post-procedural monitoring. Collaborative efforts among stakeholders are essential to optimize device safety and efficacy. Continued post-marketing surveillance and real-world data analysis are crucial for monitoring the performance of endoscopic devices and improving patient outcomes.

Document Type

Article

PubMed ID

39368716

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