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colonic FTRD Set

Ovesco Endoscopy AG · Model 14 · UDI-DI 04260206311010

PKL FDI KNS OCZ Prescription

510(k) clearances

7,363

Adverse events (25 deaths)

Recalls

Facilities

Description

The colonic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following three instruments: colonic FTRD (application cap with preloaded clip and integrated HF snare | endoscope sleeve, hand wheel and thread retriever | for colonoscopes) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD)

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.