Device Failures and Patient-related Adverse Events Associated With Small Bowel Capsule Endoscopy: a 20-year MAUDE Database Analysis.

Abstract

Background and Aims: Small bowel capsule endoscopy (SBCE) is a critical tool in the evaluation of small bowel bleeding, detection of small bowel neoplasms and diagnosing Crohn's disease (CD). The object of this study was to examine device failures and clinical adverse events in SBCE, including those involving the patency capsule (PC) system, using user- generated reports from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. 

Methods: We analyzed post marketing surveillance data for SBCE data for the most frequently used capsule system (Pillcam®) from the MAUDE database from January 2000 until January 2024.

Results: In total, 307 medical device reports with 440 device malfunctions and 675 patient-related adverse events were identified. The most reported events were entrapment of the device (n= 236, 76.9%), failure to transmit record (n= 38, 12.4%) and failure to record (n=35, 11.4%). The most commonly reported patient-related adverse events were a foreign body retained in patient (n= 154, 50.2% ), unintentional exposure to radiation (n= 122, 39.7%), and unintended exposure to anesthesia (n= 72, 23.5%).

Conclusions: Findings from the MAUDE database regarding SBCE devices provide valuable information on device failure and patient-related adverse events. This knowledge helps operators to optimize patient selection and reduce patient risk.