colonic FTRD Set 14Recalls & reported problems
Ovesco Endoscopy AG · 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) · Class 2
Quick summary
This Ovesco colonic FTRD set, used to remove colon lesions through a scope, has 94 reports, including 92 injuries and 2 deaths. Most reports describe the clip not deploying, which led to bowel perforations that were often closed during the same procedure. Reports fell from 73 in the prior 12 months to 8 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 95
- Deaths reported
- 2
- Injuries reported
- 93
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 04260206311010), received between Nov 6, 2018 and Sep 16, 2026 — classified as 2 deaths, 93 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (87 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem87
- Adverse Event Without Identified Device or Use Problem3
- Insufficient Device Problem Information3
- Activation, Positioning or Separation Problem2
- Improper or Incorrect Procedure or Method2
- Detachment of Device or Device Component1
- Failure to Fire1
- Inadequate or Insufficient Training1
Patient problems
- Bowel Perforation87
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Unspecified Gastrointestinal Problem2
- Abdominal Pain1
- Foreign Body In Patient1
- Internal Organ Perforation1
- Obstruction/Occlusion1
- Peritonitis1
Recent adverse event reports
The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Use of Device Problem
cFTRD was performed for an early carcinoma located at the left flexure. During clip deployment, the handwheel was turned, however, it was only assumed that the clip had not been deployed, although tissue resection had occurred.A resulting perforation was surgically closed and the rest of the course of the illness proceeded without complications.
Patient problems: Bowel Perforation
MAUDE report 50787774 ↗InjuryAug 11, 2026Use of Device Problem
The colonic FTRD was used for the removal of a lesion in the ascending colon in a hybrid approach of EMR followed by full thickness resection with FTRD. Assuming clip application, the resection was performed. Subsequently, incomplete clip deployment and perforation were found. The perforation was closed with conventional endoscopic clips in the same procedure and not other interventions were needed.
Patient problems: Bowel Perforation
MAUDE report 50201924 ↗InjuryJul 3, 2026Use of Device Problem
PLANNED FULL THICKNESS RESECTION (FTRD) OF A CAECAL POLYP WITH DYSPLASIA, INVOLVING THE APPENDICEAL ORIFICE. THE OVESCO CLIP WAS NOT DEPLOYED FOLLOWING ACTIVATION OF THE HAND WHEEL, AND A PERFORATION WAS SUBSEQUENTLY IDENTIFIED. THE PERFORATION WAS CLOSED DURING THE PROCEDURE.
Patient problems: Bowel Perforation
MAUDE report 25706858 ↗InjuryMay 28, 2026Use of Device Problem
THE CFTRD WAS USED FOR A FULL-THICKNESS RESECTION FOLLOWING EMR TO REMOVE A HIGH-GRADE ADENOMA. ASSUMING SUCCESSFUL CLIP APPLICATION, THE RESECTION WAS PERFORMED. SUBSEQUENTLY, NON-DEPLOYMENT OF THE CLIP WAS DETECTED. THE RESULTING PERFORATION WAS CLOSED WITH A CLIP AND SUTURES DURING THE SAME PROCEDURE.
Patient problems: Bowel Perforation
MAUDE report 25315520 ↗InjuryMar 31, 2026Use of Device Problem; Insufficient Device Problem Information
THE FTRD WAS USED FOR THE RESECTION OF A LESION IN THE AO (APPENDICEAL ORIFICE). THE CLIP WAS NOT APPLIED WHEN ATTEMPTED AND THE TISSUE WAS RESECTED, WHICH RESULTED IN A PERFORATION. THE NON-DEPLOYMENT OF THE CLIP WAS DETERMINED AS THE DEVICE WAS REMOVED FROM THE PATIENT. THE PERFORATION WAS CLOSED WITH CLIPS AND ABDOMINAL DECOMPRESSION WAS PERFORMED. THE PATIENT WAS STABLE AFTER THE PROCEDURE.
Patient problems: Bowel Perforation
MAUDE report 24742062 ↗InjuryMar 31, 2026Use of Device Problem
THE COLONIC FTRD WAS USED TO TREAT A LESION IN THE COLON ASCENDENS. THE CLIP WAS NOT DEPLOYED AND THE TISSUE WAS RESECTED. THE RESULTING PERFORATION WAS CLOSED WITH AN OTSC CLIP WITHIN THE SAME PROCEDURE. THE PATIENT RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 24738541 ↗InjuryFeb 24, 2026Use of Device Problem
THE COLONIC FTRD WAS USED FOR THE RESECTION OF A LESION IN THE AREA OF THE ILEOCECAL VALVE. DURING CLIP APPLICATION, IT WAS OBSERVED THAT THE APPLICATION RING MOVED SLIGHTLY FORWARD. DUE TO THE AMOUNT OF TISSUE IN THE CAP, FULL VISIBILITY OF THE APPLICATION RING WAS RESTRICTED. IT WAS ASSUMED THAT THE CLIP HAD BEEN APPLIED, AND THE TISSUE WAS SUBSEQUENTLY RESECTED. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS AND SUTURE.
Patient problems: Bowel Perforation
MAUDE report 24428363 ↗InjuryFeb 4, 2026Use of Device Problem
THE CFTRD WAS USED TO REMOVE AN ADENOMA AT THE COECUM. ASSUMING SUCCESSFUL CLIP APPLICATION, THE RESECTION WAS PERFORMED. AFTER THAT, THE NON-DEPLOYMENT OF THE CLIP WAS DETECTED. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT FOR THREE DAYS.
Patient problems: Bowel Perforation
MAUDE report 24255701 ↗InjuryNov 10, 2025Use of Device Problem; Failure to Fire; Use of Device Problem; Failure to Fire
THE COLONIC FTRD WAS USED FOR THE TREATMENT OF AN ADENOMA IN THE ASCENDING COLON. THE CLIP WAS NOT DEPLOYED BEFORE RESECTING THE TISSUE. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PRODEDURE. THE PATIENT RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 23509833 ↗InjurySep 10, 2025Use of Device Problem; Use of Device Problem
THE CFTRD WAS USED TO TREAT A RECTAL LESION. A LARGE AMOUNT OF TISSUE WAS MOBILIZED INTO THE CAP AND THE APPLICATION RING WAS NOT OBSERVED. AFTER TURNING THE HANDWHEEL, THE USER ASSUMED CLIP APPLICATION WITHOUT VISUAL CONTROL. THE CLIP WAS NOT DEPLOYED BUT TISSUE WAS RESECTED. THE RESULTING PERFORATION WAS CLOSED BY SURGERY. THE PATIENT RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 23013392 ↗InjuryAug 7, 2025Use of Device Problem; Use of Device Problem
THE COLONIC FTRD WAS USED FOR THE TREATMENT OF AN ADENOMA IN THE HEPATIC FLEXURE. AFTER TURNING THE HANDWHEEL, THE CLIP WAS NOT APPLIED AND THE TISSUE WAS RESECTED. THE RESULTING PERFORATION WAS CLOSED WITH A CLIP WITHIN THE SAME PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR MONITORING AND RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22735501 ↗InjuryJul 25, 2025Use of Device Problem; Use of Device Problem
THE COLONIC FTRD WAS USED TO TREAT A NET IN THE RECTUM. DURING PROCEDURE THE THREAD RUPTURED BUT THIS WAS NOT NOTICED. DUE TO A LARGE AMOUNT OF TISSUE IN THE CAP THE WHITE APPLICATION RING WAS NOT OBSERVED. CLIP APPLICATION WAS NOT VERIFIED BEFORE TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITHIN THE SAME PROCEDURE WITH CLIPS. THE PATIENT RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22606998 ↗InjuryJul 16, 2025Use of Device Problem; Use of Device Problem
THE COLONIC FTRD WAS USED FOR THE TREATMENT OF AN ADENOMA IN THE COECUM. DUE TO A LARGE AMOUNT OF TISSUE IN THE CAP, THE CLIP APPLICATION WAS NOT VERIFIED BY THE USER PRIOR TO TISSUE RESECTION. THE PERFORATION WAS CLOSED WITH A CLIP. THE HAEMORRHAGE NEEDED TO BE TREATED SURGICALLY. THE PATIENT WAS ADMITTED TO THE ICU.
Patient problems: Bowel Perforation
MAUDE report 22517776 ↗InjuryJul 10, 2025Use of Device Problem; Use of Device Problem
THE COLONIC FTRD WAS USED FOR THE TREATMENT OF A NEUROENDOCRINE TUMOR IN THE RECTUM. THE CLIP APPLICATION WAS NOT VERIFIED PRIOR TO TISSUE RESECTION DUE TO A LARGE AMOUNT OF TISSUE AND BLOOD IN THE CAP. THE RESULTING PERFORATION WAS CLOSED WITH AN OVERSTITCH DEVICE WITHIN THE SAME PROCEDURE. NO ADDITIONAL TREATMENT WAS NECESSARY AND THE PATIENT RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22466431 ↗InjuryMay 21, 2025Use of Device Problem; Use of Device Problem
DURING AN INTERVENTION WITH CFTRD FOR FULL TISSUE RESECTION IN THE CAECUM, CLIP DEPLOYMENT WAS NOT VERIFIED BY THE OPERATOR BEFORE TISSUE RESECTION. THE RESULTING PERFORATION REQUIRED CLOSURE WITH ONE 14/6 OTSC CLIP. THE PATIENT RECOVERED WITHOUT ANY FURTHER TREATMENT.
Patient problems: Bowel Perforation
MAUDE report 22058412 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED TO TREAT AN ADENOMA AT THE APPENDIX. DUE TO A LARGE AMOUNT OF TISSUE MOBILIZED INTO THE CAP, THE WHITE APPLICATION RING WAS NOT VISIBLE. AFTER TURNING THE HAND WHEEL, THE TISSUE WAS RESECTED WITHOUT VERIFYING SUCCESSFUL CLIP APPLICATION. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE.
Patient problems: Bowel Perforation
MAUDE report 22025558 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED TO TREAT AN ADENOMA IN THE RIGHT FLEXURE. THE USER TURNED THE HAND WHEEL AND DUE TO THE RESULTING HAPTIC IMPRESSION ON THE HANDWHEEL, THE USER MISTAKENLY ASSUMED THAT THE CLIP HAD ALREADY BEEN DEPLOYED WHEN HE PERFORMED THE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH A CLIP WITHIN THE SAME PROCEDURE.
Patient problems: Bowel Perforation
MAUDE report 22025551 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT COLONIC FTRD WAS USED FOR THE TREATMENT OF AN ADEMONA AT THE APPENDIX. CLIP APPLICATION WAS NOT VERIFIED BEFORE TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH A CLIP.
Patient problems: Bowel Perforation
MAUDE report 22025536 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED FOR THE TREATMENT OF AN ADENOMA IN THE APPENDIX AREA. DUE TO A LARGE AMOUNT OF TISSUE IN THE CAP, THE VIEW OF THE WHITE APPLICATION RING WAS RESTRICTED AND THE SUCCESSFUL CLIP APPLICATION WAS THEREFORE NOT VERIFIED BEFORE TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. THE PATIENT STAYED IN ICU OVERNIGHT AND RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22025529 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED FOR THE TREATMENT OF AN ADENOMA IN THE ASCENDING COLON. THE USER MISTAKENLY CONSIDERED THE SLIGHT ONE-SIDED FORWARD MOVEMENT OF THE WHITE APPLICATION RING AS CLIP APPLICATION AND RESECTED THE TISSUE. THE RESULTING PERFORATION WAS THEN CLOSED WITH CLIPS. THE PATIENT RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22025510 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED FOR THE TREATMENT OF A LESION IN THE TRANSVERSE COLON. DUE TO A LARGE AMOUNT OF TISSUE MOBILIZED INTO THE CAP, THE VIEW OF THE WHITE APPLICATION RING WAS LIMITED. AFTER TURNING THE HAND WHEEL, THE APPLICATION RING MOVED SLIGHTLY FORWARD. THIS WAS MISINTERPRETED AS SUCCESSFUL CLIP APPLICATION. THE TISSUE WAS RESECTED SUBSEQUENTLY AND A PERFORATION OCCURRED. THE PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. THE PATIENT WAS DISCHARGED FROM HOSPITAL THE FOLLOWING DAY.
Patient problems: Bowel Perforation
MAUDE report 22025508 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED FOR THE TREATMENT OF A SCARRED LESION IN THE ASCENDING COLON. AFTER TURNING THE HAND WHEEL THE WHITE APPLICATION RING SLIGHTLY ADVANCED ON ONE SIDE. IT WAS MISTAKENLY ASSUMED THAT THE CLIP HAD BEEN APPLIED AND THE TISSUE WAS RESECTED. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. THE CLIP EVENTUALLY DEPLOYED OUTSITE THE PATIENT. THE PATIENT STAYED IN HOSPITAL OVERNIGHT AND RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22025504 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED FOR THE TREATMENT OF A POLYP IN THE RECTUM. AFTER TURNING THE HAND WHEEL, THE WHITE APPLICATION RING MOVED SLIGHTLY FORWARDS ON ONE SIDE. THIS WAS MISTAKENLY CONSIDERED A CLIP APPLICATION BY THE USER. THE TISSUE WAS SUBSEQUENTLY RESECTED. THE RESULTING PERFORATION WAS CLOSED WITH A CLIP. THE PATIENT STAYED IN HOSPITAL FOR ANOTHER DAY AND RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22025503 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED FOR THE TREATMENT OF A LESION IN THE RECTUM. THE TISSUE MOBILIZATION WAS DESCRIBED AS DIFFICULT. THE VIEW OF THE WHITE APPLICATION RING WAS LIMITED DUE TO BLEEDING. WHEN ATTEMPTING TO DEPLOY THE CLIP, THE WHITE APPLICATION RING WENT OUT OF VISION. THE USER HENCE ASSUMED SUCCESSFUL CLIP APPLICATION AND RESECTED THE TISSUE SUBSEQUENTLY. THE RESULTING PERFORATION WAS THEN CLOSED WITH CLIPS. THE PATIENT REQUIRED NO FURTHER TREATMENT.
Patient problems: Bowel Perforation
MAUDE report 22025330 ↗InjuryMay 15, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE COLONIC FTRD WAS USED TO TREAT AN ADENOMA IN THE APPENDIX. THE CLIP APPLICATION WAS NOT VERIFIED BEFORE TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. THE PATIENT RECOVERED WELL.
Patient problems: Bowel Perforation
MAUDE report 22024223 ↗
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- 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
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract87 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.