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OTSC System Set
Ovesco Endoscopy Usa, Inc. · Model 12/6 gc · UDI-DI 04260206311652
PKL
Prescription
1
510(k) clearances
7,243
Adverse events (25 deaths)
6
Recalls
54
Facilities
Description
The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-03 | Wilson-Cook Medical Inc. | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2023-05-04 | Olympus Corporation of the Americas | Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, poten |
| 2019-02-04 | US Endoscopy Group Inc | Potential esophageal laceration during a patient procedure |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.