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
Research motivation

Gold probe (GP) and gold probe (GP) are vital in managing gastrointestinal bleeding, yet they present notable risks. Awareness of these risks is essential for endoscopists and support staff. The study highlights the need for improved device safety and better management strategies in case of device failure.

Research objectives

The analysis revealed 140 reports for GP and 202 reports for IGP, with the majority of device failures being attributed to the failure to deliver energy. While most events did not lead to significant patient consequences, a notable proportion (26% for IGP) resulted in adverse outcomes like prolonged hemorrhage or the need for secondary procedures.

Research methods

The study utilized post-marketing surveillance data from the Food and Drug Administration (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database, analyzing reports for GP and IGP from January 2013 to August 2023. Statistical analyses were performed using IBM SPSS Statistics V.27.0 to identify primary and secondary outcome measures.

Research results

The primary objective is to evaluate the events associated with the use of GP and IGP, specifically focusing on the types and frequencies of device failures and their impact on patient outcomes.

Research conclusions

The motivation for this research stems from the lack of comprehensive data on device-related adverse events for GP and IGP, devices commonly used in managing gastrointestinal bleeding, despite their widespread clinical use.

Research perspectives

This study investigates the device-related adverse events associated with the use of GP and IGP in endoscopic hemostasis, leveraging data from the FDA's MAUDE database over a decade (2013-2023).

Research background

The findings underscore the need for ongoing surveillance, device improvement, and consideration of emerging hemostatic technologies. Further research into device design and usage guidelines could enhance safety and efficacy in clinical practice.