OTSC System Set 11/6 tRecalls & reported problems
Ovesco Endoscopy AG · 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 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260206310082), received between May 14, 2024 and May 14, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Misassembly by Users” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Misassembly by Users1
Patient problems
- Bowel Perforation1
- Peritonitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 14, 2024Adverse Event Without Identified Device or Use Problem; Misassembly by Users; Adverse Event Without Identified Device or Use Problem; Misassembly by Users
IT WAS REPORTED THAT AFTER COLORECTAL POLYP REMOVAL, THE REMOVAL SITE WAS CLOSED WITH AN OTSC CLIP IN A EXTRA TIGHT MANNER AS A PRECAUTION AGAINST POSSIBLE BLEEDING DUE TO DUAL ANTICOAGULATION OF THE PATIENT. DUE TO INCOMPLETE ADVANCEMENT OF THE ENDOSCOPE TIP INTO THE OTSC CAP UPON DEVICE INSTALLATION, A LARGER SPACE INSIDE THE CAP RESULTED. WHEN ASPIRATING THE RECTAL TARGET TISSUE INTO THE CAP ADJACENT JEJUNAL TISSUE WAS INADVERTENTLY ENTRAPPED AND CLIPPED. THIS LED TO SECONDARY PERFORATION OF THE BOWEL LOOP A FEW DAYS AFTER AND RESULTED IN PERITONITIS. THE PATIENT HAD TO BE TREATED SURGICALLY. DUE TO THE PATIENT'S ADVANCED UNDERLYING MALIGNANT DISEASE, HE DID NOT RECOVER UNDER POSTOPERATIVE CARE AND DIED A FEW DAYS LATER.
Patient problems: Bowel Perforation; Peritonitis
MAUDE report 19307312 ↗
Other Hemostatic Metal Clip For The Gi Tract devices
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- Resolution Clip M00522610Boston Scientific Corporation · Hemostatic metal clip for the GI tract1,116 reports
- Instinct G58010Cook Incorporated · Hemostatic metal clip for the GI tract1 recall1,017 reports
- Resolution 360™ ULTRA Clip M00521400Boston Scientific Corporation · Hemostatic metal clip for the GI tract3 deaths496 reports
- Instinct G18343Cook Incorporated · Hemostatic metal clip for the GI tract244 reports
- MANTIS™ Clip M00521420Boston Scientific Corporation · Hemostatic metal clip for the GI tract195 reports
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract1 recall118 reports
- colonic FTRD Set 14Ovesco Endoscopy AG · Hemostatic Metal Clip For The Gi Tract2 deaths95 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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