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mini OTSC System Set
Ovesco Endoscopy AG · Model mini/6 a · UDI-DI 04260206311232
PKL
Prescription
1
510(k) clearances
7,363
Adverse events (25 deaths)
6
Recalls
54
Facilities
Description
The mini OTSC System extends the OTSC System by a smaller size • it can be used for the same indications as the OTSC System means acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • can especially be used in small lumen or where access is an issue • 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.