Adverse events associated with the gold probe and the injection gold probe devices used for endoscopic hemostasis: A MAUDE database analysis

Abstract

BACKGROUND Gastrointestinal (GI) bleeding accounts for over half a million admissions annually and is the most common GI diagnosis requiring hospitalization in the United States. Bipolar electrocoagulation devices are used for the management of gastrointestinal bleeding. There is no data on device-related adverse events for gold probe (GP) and injection gold probe (IGP). AIM To analyze this using the Food and Drug Administration (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database from 2013 to 2023. METHODS We examined post-marketing surveillance data on GP and IGP from the FDA MAUDE database to report devicerelated and patient-related adverse events between 2013-2023. The MAUDE database is a publicly available resource providing over 4 million records relating to medical device safety. Statistical analyses were performed using IBM SPSS Statistics V.27.0 (IBM Corp., Armonk, NY, United States). RESULTS Our search elicited 140 reports for GP and 202 reports for IGP, respectively, during the study period from January 2013 to August 2023. Malfunctions reportedly occurred in 130 cases for GP, and actual patient injury or event occurred in 10 patients. A total of 149 patients (74%) reported with Injection GP events suffered no significant consequences due to the device failure, but 53 patients (26%) were affected by an event. CONCLUSION GP and IGP are critical in managing gastrointestinal bleeding. This study of the FDA MAUDE database revealed the type, number, and trends of reported device-related adverse events. The endoscopist and support staff must be aware of these device-related events and be equipped to manage them if they occur.