Observational Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jan 16, 2024; 16(1): 37-43
Published online Jan 16, 2024. doi: 10.4253/wjge.v16.i1.37
Adverse events associated with the gold probe and the injection gold probe devices used for endoscopic hemostasis: A MAUDE database analysis
Vishnu Charan Suresh Kumar, Mark Aloysius, Ganesh Aswath
Vishnu Charan Suresh Kumar, Mark Aloysius, Ganesh Aswath, Division of Gastroenterology and Hepatology, SUNY Upstate Medical University, Syracuse, NY 13202, United States
Author contributions: Suresh Kumar VC contributed to conceptualization, design, manuscript writing, and editing; Aloysius M contributed to design, statistical analysis, manuscript writing, and editing; Aswath G contributed to manuscript review and editing.
Institutional review board statement: This is a de-identified database-based study thus it was determined that no ethical approval/IRB is required.
Informed consent statement: For this study, we utilized a de-identified database, specifically the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which contains anonymized and publicly available data. Given the retrospective and de-identified nature of the data analyzed, this study did not involve direct interaction with patients or access to identifiable patient information. Consequently, in accordance with ethical guidelines and research standards, informed consent was not required for this database-based study.
Conflict-of-interest statement: There are no conflicts of interest to report.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Vishnu Charan Suresh Kumar, MBBS, Doctor, Division of Gastroenterology and Hepatology, SUNY Upstate Medical University, 750 E Adams Street, Syracuse, NY 13202, United States. kumarv@upstate.edu
Received: October 9, 2023
Peer-review started: October 9, 2023
First decision: November 16, 2023
Revised: November 22, 2023
Accepted: December 5, 2023
Article in press: December 5, 2023
Published online: January 16, 2024
Core Tip

Core Tip: Gold probe (GP) and injection gold probe (IGP) are critical in managing gastrointestinal bleeding. This study of the Food and Drug Administration Manufacturer and User Facility Device Experience database revealed the type, number, and trends of reported device-related adverse events. 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. 149 patients (74%) reported with IGP events suffered no significant consequences due to the device failure, but 53 patients (26%) were affected by an event. The endoscopist and support staff must be aware of these device-related events and be equipped to manage them if they occur.