Abstract
INTRODUCTION: The malfunction of capsule endoscopy (CE) devices is a significant reason for the failure of CE procedures, which could hinder and prevent diagnosis. Unfortunately, malfunction-related adverse events (AEs) caused by CE devices are rarely reported in publications. Although most malfunction-related AEs could not lead to physical harm, they could reduce the efficiency of medical care and increase medical costs. The manufacturer and user facility device experience (MAUDE) database, a publicly accessible resource for patient safety, contains not only the common complications of CE but also valuable malfunction-related AEs, which have been underutilized. Therefore, the study aims to discover and analyze the possible AEs associated with CE and demonstrate the utility of the MAUDE reports to promote patient safety. MATERIALS AND METHODS: We acquired MAUDE reports of CE systems from January 01, 2008, to July 31, 2020, through a systematic search strategy. We utilized the manufacturers, brand names, and product codes as search terms from which medical device reports including structured data and narrative texts were extracted, followed by a manual review of the narrative texts, reporter occupation, device involved, event type and the phase of the event; finally, patient outcomes were recorded and analyzed as per CE categories and characteristics. RESULTS: A total of 377 CEs medical device reports were retrieved, and 342 reports were included after reviewing. There were 327 mandatory reports (96%) and 15 voluntary reports (4%). These reports referred to capsule endoscope (n = 213), sensing system (n = 66), patency capsule (n = 38), and capsule delivery device (n = 26). A total of 349 CE-related AEs were identified, including complications (n = 228), malfunction-related AEs (n = 109), and other events (n = 12). The composition of AEs was not the same for the CE devices. Complications were major AEs of capsule endoscope and patency capsule, but malfunction-related AEs were the most common in AEs of sensing systems and capsule delivery devices. CONCLUSION: MAUDE serves as an invaluable data source for investigating malfunction-related AEs. In addition to common complications, malfunction of CE devices could threaten patient safety in CE procedures. Improving awareness of the malfunction of CE devices and raising adequate training for staff working in gastrointestinal (GI) endoscopic units could be critical and beneficial in preventing malfunction-related AEs.