Photo Credit: Beerkoff
The following is a summary of Adverse Events of Endoscopic Clip Placement A MAUDE Database Analysis,” published in the January 2024 issue of Gastroenterology by Ramai, et al.
Endoscopic clips are strong mechanical devices that can close and stretch around the tissue to stop bleeding through a tamponade effect. Endoscopic practice uses clips, and many studies have shown that they work. New standards suggest clips as the first treatment for recurring and ongoing nonvariceal gastric bleeding. But these devices still need to get a clear safety rating. For a study, researchers sought to look into it by analyzing the bad things reported to the Food and Drug Administration.
From January 2012 to January 2021, postmarketing monitoring records from the Food and Drug Administration Manufacturer And User Facility Device Experience database were examined. The Manufacturer And User Facility Device Experience database is just a reporting tool; it doesn’t check the details of problems on its own.
About 2,766 reports were sent in. Of these, 287 were about bad things that happened to patients, and 2,766 were about device problems. The most common problems were with activation, separation, and placement. In the 1,968 accounts, no clinically important effects or outcomes on patients existed. There were 97 cases of foreign bodies, 57 cases of bleeding, 42 cases of tissue damage, 16 cases of clips stuck in tissues or plaques, 15 cases of puncture, 6 cases of lacerations, and 3 cases of. The most common problems with the device were activation, separation, and setting. However, most patients did not have any clinical effects. Additionally, rupture and infection were uncommon, adding to the safety rating of endoscopic clips.
Source: journals.lww.com/jcge/abstract/2024/01000/adverse_events_of_endoscopic_clip_placement__a.12.aspx
