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1/15/2024 4:38:18 AM | Browse: 79 | Download: 149
Publication Name World Journal of Gastrointestinal Endoscopy
Manuscript ID 88799
Country United States
Received
2023-10-09 18:13
Peer-Review Started
2023-10-09 18:15
To Make the First Decision
Return for Revision
2023-11-16 05:58
Revised
2023-11-22 02:04
Second Decision
2023-11-28 01:45
Accepted by Journal Editor-in-Chief
Accepted by Company Editor-in-Chief
2023-12-05 05:37
Articles in Press
2023-12-05 05:37
Publication Fee Transferred
Edit the Manuscript by Language Editor
Typeset the Manuscript
2024-01-10 07:59
Publish the Manuscript Online
2024-01-15 04:38
ISSN 1948-5190 (online)
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: http://creativecommons.org/licenses/by-nc/4.0/
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
Article Reprints For details, please visit: http://www.wjgnet.com/bpg/gerinfo/247
Permissions For details, please visit: http://www.wjgnet.com/bpg/gerinfo/207
Publisher Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
Website http://www.wjgnet.com
Category Gastroenterology & Hepatology
Manuscript Type Observational Study
Article Title Adverse events associated with the gold probe and the injection gold probe devices used for endoscopic hemostasis: A MAUDE database analysis
Manuscript Source Unsolicited Manuscript
All Author List Vishnu Charan Suresh Kumar, Mark Aloysius and Ganesh Aswath
ORCID
Author(s) ORCID Number
Vishnu Charan Suresh Kumar http://orcid.org/0000-0002-9472-2869
Mark Aloysius http://orcid.org/0000-0001-6191-0524
Ganesh Aswath http://orcid.org/0000-0002-1354-9225
Funding Agency and Grant Number
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
Key Words Hemostasis; Gastrointestinal bleeding; Endoscopy; Device failure; Bipolar coagulation; Cautery; Risks
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.
Publish Date 2024-01-15 04:38
Citation Suresh Kumar VC, Aloysius M, Aswath G. Adverse events associated with the Gold Probe and the Injection Gold Probe devices used for endoscopic hemostasis: A MAUDE database analysis. World J Gastrointest Endosc 2024; 16(1): 37-43
URL https://www.wjgnet.com/1948-5190/full/v16/i1/37.htm
DOI https://dx.doi.org/10.4253/wjge.v16.i1.37
Full Article (PDF) WJGE-16-37-with-cover.pdf
Full Article (Word) WJGE-16-37.docx
STROBE Statement 88799-STROBE statement.pdf
Manuscript File 88799_Auto_Edited-LJH-JLW.docx
Answering Reviewers 88799-Answering reviewers.pdf
Audio Core Tip 88799-Audio core tip.mp3
Biostatistics Review Certificate 88799-Biostatistics statement.pdf
Conflict-of-Interest Disclosure Form 88799-Conflict-of-interest statement.pdf
Copyright License Agreement 88799-Copyright license agreement.pdf
Signed Informed Consent Form(s) or Document(s) 88799-Informed consent statement.pdf
Peer-review Report 88799-Peer-review(s).pdf
Scientific Misconduct Check 88799-Bing-Liu JH-2.png
Scientific Misconduct Check 88799-CrossCheck.png
Scientific Editor Work List 88799-Scientific editor work list.pdf