Hemostatic Metal Clip For The Gi Tract
Gastroenterology, Urology · 21 CFR 876.4400
Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.
Recent MDR events
7,146 adverse event reports on file
- INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICEJul 31, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00373
- Hemostatic Metal Clip for the GI TractJul 30, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03096
- Resolution 360 ClipJul 29, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03074
- Resolution 360 ClipJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03057
- InstinctJul 28, 2026MalfunctionCook Incorporated50053114
- Resolution 360 ClipJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03061
- INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICEJul 28, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00368
- INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICEJul 28, 2026InjuryWilson-cook Medical Inc1037905-2026-00369
- MANTIS? ClipJul 28, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03070
- Resolution 360 ClipJul 27, 2026MalfunctionBoston Scientific Corporation3005099803-2026-03050
Event type breakdown
Recalls
6 recall events for this product code
- Wilson-Cook Medical Inc.Open, ClassifiedApr 13, 2026
Instinct Plus Endoscopic Clipping Device
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Z-1812-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJun 21, 2023
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Z-1987-2023 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJun 21, 2023
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Z-1988-2023 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJun 21, 2023
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Z-1989-2023 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJun 21, 2023
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Z-1990-2023 · View FDA record ↗ - US Endoscopy Group IncTerminatedUnknown
US Endoscopy Padlock Clip defect closure system
Potential esophageal laceration during a patient procedure
Z-1011-2019 · View FDA record ↗
Registered firms
120 firms currently registered for this product code
United States Endoscopy Group, Inc.
Mentor, OH, US
Micro-tech (nanjing) Co., Ltd.
NAN JING Jiangsu, CN
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.
Ji 'an Jiangxi, CN
Radia Industry Co., Ltd.
Takasaki Gunma, JP
Ovesco Endoscopy Ag
Tuebingen Baden-Wurttemberg, DE
Boston Scientific Limited
GALWAY, IE
Ovesco Endoscopy Usa
Cary, NC, US
Ningbo Huakun Medical Equipment Co.,ltd
Cixi Zhejiang, CN
Micro-tech (nanjing) Co., Ltd.
Nanjing Jiangsu, CN
Bq Plus Medical Co.,ltd
SONGJIANG Shanghai, CN
Boston Scientific Corporation
Marlborough, MA, US
Cbr Enterprise Limited
Hong Kong, HK
Boston Scientific Corporation
Coventry, RI, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
510(k) clearances
63 clearances for this product code
- Olympus Medical Systems Corp.May 21, 2026
K260580 · Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
- Hangzhou AGS MedTech Co., Ltd.Apr 8, 2026
K252270 · Hemoclip
- Taurus EndoscopyMar 12, 2026
K253734 · Taurus Clip
- Ovesco Endoscopy AGDec 18, 2025
K251562 · OTSCneo System Set (100.03n-14n, 100.27n-31n)
- Hangzhou AGS MedTech Co., Ltd.Nov 12, 2025
K252271 · Hemoclip
- Micro-Tech (Nanjing) Co., Ltd.Sep 8, 2025
K250229 · Dual Action Tissue Closure Device
- STERIS CorporationApr 18, 2025
K250842 · PADLOCK CLIP EFTR Kit (00713229)
- Boston Scientific CorporationFeb 6, 2025
K250066 · Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)