Analysis of reported adverse events related to single-use duodenoscopes and duodenoscopes with detachable endcaps

摘要

Background and Aims: Single-use duodenoscopes and duodenoscopes with detachable/disposable caps emerged in the market to mitigate the risk of ERCP-related infections. We aimed to investigate adverse events associated with these devices occurring after U.S. Food and Drug Administration (FDA) approval. Methods: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from July 2018 to June 2021. Results: One hundred eighty-five reports comprising 201 device issues and 118 patient adverse events were identified from July 2018 through June 2021. Most device issues related to the single-use duodenoscope were due to optical problems (7 reports). Other reported device issues included difficulty in advancing the duodenoscope (2 reports), fluid leak (2 reports), and use-of-device problems (2 reports). Among the duodenoscopes with detachable/disposable caps, most device issues were related to bacterial contamination (53 reports), followed by issues with device use (31 reports), detachment/separation of the device (25 reports), and crack/dent in device material (16 reports). Overall, the most frequently reported patient adverse events were tissue injury (63 reports), perforation (8 reports), and bleeding (7 reports). Ninety reports of microbial contamination of duodenoscopes with detachable/disposable caps were identified, of which Pseudomonas aeruginosa was most common. Conclusions: Findings from the MAUDE database highlight patient and device adverse events that endoscopists should be aware of in using single-use duodenoscopes and duodenoscopes with detachable/ disposable caps. Whereas these devices mitigate the risk of transmitting infection, they are associated with additional device-associated adverse events.