Adverse events of the endoscopic over-the-scope clips and cutters: a Manufacturer and User Facility Device Experience database analysis.

BACKGROUND AND AIMS

The Ovesco clip system (Tübingen, Germany), including the over-the-scope clip and full-thickness resection device, has demonstrated efficacy in managing various GI pathologies. However, real-world data on device malfunctions and patient adverse events are limited. This study aimed to analyze adverse events associated with Ovesco clips and cutters reported to the U.S. Food and Drug Administration 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 adverse events were extracted. Descriptive statistics were used to summarize the findings.

RESULTS

Forty-two reports were identified, with 41 involving Ovesco clips and 1 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%). GI perforation was the most frequently reported patient adverse event (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.

CONCLUSIONS

Ovesco clips and cutters are associated with potential device malfunctions and patient adverse events, particularly GI perforation. The findings highlight the need for careful patient selection, meticulous technique, and close postprocedural monitoring. Collaborative efforts among stakeholders are essential to optimize device safety and efficacy. Continued postmarketing surveillance and real-world data analysis are crucial for monitoring the performance of endoscopic devices and improving patient outcomes.