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stentfix OTSC System Set

Ovesco Endoscopy Usa, Inc. · Model stentfix · UDI-DI 04260206311706

PKL OCZ Prescription

510(k) clearances

7,243

Adverse events (25 deaths)

Recalls

Facilities

Description

The stentfix 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 the fixation of self-expandable metallic stents in the gastrointestinal tract (for adult use only) • the modified clip adapts optimally to the gastrointestinal anatomy • the clip is anchored in the tissue and on the stent mesh so that the stent is fixed to the tissue and secured against migration • made of a biocompatible material (Nitinol) and exerts a constant force on the tissue in the application area, thus securing the positioning of the stent • 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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Data 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.