Device failures and patient-related adverse events with small bowel capsule endoscopy: a 20-year MAUDE database analysis.

Abstract

Background: 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. The object of this study was to examine device failures (DF) and patient-related adverse events (PRAE) in SBCE, including those involving the patency capsule system, using user-generated reports from the US Food and Drug Administration's (FDA) Manufacturer and User facility Device Experience (MAUDE) database.

Method: We analyzed post marketing surveillance data for SBCE data for all of the SBCE systems from the FDA's MAUDE database from January 2000 until December 2023.

Results: A total of 352 reports were obtained during the study period, pertaining to the following SBCE systems, in descending order of frequency: Pillcam SB^® system, Pillcam^® Patency Capsule, Endocapsule^®, CapsoCam^® and MiroCam^®. The vast majority pertained to the Pillcam^® and Pillcam^® Patency system: a total of 307 medical device reports with 398 DFs and 569 PRAEs. The most reported DFs were entrapment of the device (n=212, 53.2%), failure to transmit record (n=38, 9.5%), and failure to record (n=35, 8.7%). The most commonly reported PRAEs were a foreign body retained in the patient (n=140, 24.6%), unintentional exposure to radiation (n=104, 18.2%), and unintended exposure to anesthesia (n=58, 10.2%).

Conclusions: Findings from the MAUDE database regarding SBCE devices provide valuable information on DFs and PRAEs. This knowledge can help operators optimize patient selection and reduce patient risk.