Analysis of Reported Adverse Events Associated With the Use of Functional Lumen Imaging Probe Devices in the Esophagus and Stomach: An FDA MAUDE Database Study

Abstract

The endoscopic Functional Lumen Imaging Probe (FLIP) devices are used to evaluate pressure changes, diameter, and volume of the esophagus. We used the FDA’s MAUDE database to collect post-marketing surveillance data on these devices from January 2009 to September 2022. Forty-Five device-related events and thirty-six patient-related adverse events were analyzed. The most common device issue for the diagnostic FLIP device was therapeutic/diagnostic failure (n = 6), while the most frequent issue with the therapeutic FLIP device was adverse events without an identified device or use problem (n = 11). Patient-related adverse events were extremely rare with the diagnostic FLIP and the most common patient-related adverse event with the therapeutic FLIP was perforation (n = 11). Endoscopists need to be mindful of these potential technical issues and adverse events while using these devices.