diagnostic FTRD Set 13Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04260206311072), received between Feb 13, 2019 and Jan 22, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (10 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Use of Device Problem

  THE DFTRD WAS USED TO REMOVE A POLYP IN THE CECUM. AFTER TURNING THE HANDWHEEL, THE APPLICATION RING MOVED PAST VISUALIZATION DUE TO A LARGE AMOUNT OF TISSUE IN THE CAP. ASSUMING SUCCESSFUL CLIP APPLICATION, THE RESECTION TOOK PLACE. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE. DUE TO SUSPECTED PERITONITIS, THE PATIENT WAS SENT FOR SURGERY.

  Patient problems: Bowel Perforation

  MAUDE report 24142053 ↗
• InjuryMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DIAGNOSTIC FTRD WAS USED TO TREAT AN ADENOMA AT THE APPENDICEAL ORIFICE. THE CLIP APPLICATION WAS NOT VERIFIED PRIOR TO TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH CLIPS WITHIN THE SAME PROCEDURE.

  Patient problems: Bowel Perforation

  MAUDE report 22025516 ↗
• InjuryMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DIAGNOSTIC FTRD WAS USED TO TREAT AN ADENOMA IN THE APPENDICEAL ORIFICE. 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 SUCCESSFUL CLIP APPLICATION WAS NOT VERIFIED PRIOR TO TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH A CLIP WITHIN THE SAME PROCEDURE.

  Patient problems: Bowel Perforation

  MAUDE report 22025339 ↗
• InjuryMay 15, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DIAGNOSTIC FTRD WAS USED TO TREAT A LESION IN THE DUODENUM. CLIP APPLICATION WAS NOT VERIFIED BEFORE TISSUE RESECTION. THE RESULTING PERFORATION WAS CLOSED WITH A CLIP. THIS CLIP HAD TO BE REMOVED DUE TO INCOMPLETE PERFORATION CLOSURE. DURING ENDOSCOPE RETRACTION AND CLIP REMOVAL, THE PATIENT´S ESOPHAGUS WAS ACCIDENTALLY INJURED BY THE CLIP. THE BOWEL PERFORATION WAS CLOSED WITH OVERSTITCHING AND ANOTHER CLIP. THE ESOPHAGEAL TEAR WAS THEN CLOSED WITH ENDOCLIPS. THE PATIENT STAYED IN HOSPITAL OVERNIGHT AND SCANS WERE SCHEDULED FOR THE FOLLOWING DAY.

  Patient problems: Bowel Perforation; Laceration(s) of Esophagus

  MAUDE report 22024220 ↗
• InjuryMay 15, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DIAGNOSTIC FTRD WAS USED FOR THE TREATMENT OF A LESION IN THE CARDIA. THE USER MISTAKENLY INTERPRETED THE SLIGHT ONE-SIDED FORWARD MOVEMENT OF THE WHITE APPLICATION RING AS CLIP APPLICATION. THE TISSUE WAS RESECTED SUBSEQUENTLY LEADING TO A PERFORATION. THE PERFORATION WAS CLOSED WITH CLIPS AND THE PATIENT WAS ADMITTED TO THE HOSPITAL.

  Patient problems: Internal Organ Perforation

  MAUDE report 22024217 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  DURING AN INTERVENTION IN THE RECTO SIGMOID FOR EFTRD, CLIP DEPLOYMENT WAS MISTAKENLY ASSUMED AND NOT VISUALLY VERIFIED PRIOR TO RESECTION OF THE TARGET TISSUE. THE RESULTING SUPERFICIAL PERFORATION WAS CLOSED WITH 4 MANTIS CLIP. THE PATIENT RECOVERED WITHOUT ANY FURTHER TREATMENT.

  Patient problems: Bowel Perforation

  MAUDE report 22017651 ↗
• InjuryMay 14, 2025Use of Device Problem; Use of Device Problem

  DURING AN INTERVENTION IN THE CAECUM FOR EFTR, CLIP DEPLOYMENT WAS MISTAKENLY ASSUMED WHILE THE THREAD WAS BROKEN. CORRECT CLIP APPLICATION WAS NOT VISUALLY CONTROLLED, AND THE TARGET TISSUE WAS SUBSEQUENT RESECTED. THE RESULTING PERFORATION WAS CLOSED WITH 7 TTS CLIP. THE PATIENT WAS ADMITTED OVERNIGHT AND DID WELL WITHOUT ANY COMPLICATIONS.

  Patient problems: Bowel Perforation

  MAUDE report 22017630 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEW DAYS AFTER ENDOSCOPIC RESECTION AT THE APPENDICEAL ORIFICE WITH DFTRD, THE PATIENT DEVELOPED APPENDICITIS. THE APPENDICITS REQUIRED SURGICAL APPENDECTOMY.

  Patient problems: Abdominal Pain; Unspecified Gastrointestinal Problem

  MAUDE report 20693047 ↗
• InjurySep 13, 2022Use of Device Problem; Use of Device Problem

  A DIAGNOSTIC FTRD SET (DFTRD), MANUFACTURER OVESCO ENDOSCOPY AG, WAS USED FOR AN ENDOSCOPIC FULL THICKNESS RESECTION OF A POLYP AT APPENDICAL ORIFICE. THE ENDOSCOPIC INTERVENTIONIST ASSUMED THAT THE CLIP OF THE DIAGNOSTIC FTRD SET IN QUESTION HAD BEEN APPLIED AND, HENCE, PROCEEDED TO PERFORM THE FULL THICKNESS RESECTION. HOWEVER, CLIP APPLICATION WAS VISUALLY NOT VERIFIED BEFOREHAND. THE CAUSED PERFORATION WAS CLOSED BY SURGERY. AS REPORTED THE PATIENT RECOVERED UNEVENTFULLY.

  Patient problems: Bowel Perforation

  MAUDE report 15410482 ↗
• InjuryJun 1, 2022Use of Device Problem; Use of Device Problem

  A DIAGNOSTIC FTRD SET (DFTRD), MANUFACTURER OVESCO ENDOSCOPY AG, WAS USED FOR AN ENDOSCOPIC FULL THICKNESS RESECTION OF A 2 CM SIZE LESION IN THE CECUM. THE ENDOSCOPIC INTERVENTIONIST ASSUMED THAT THE CLIP OF THE DIAGNOSTIC FTRD SET IN QUESTION HAD BEEN SUCCESSFULLY APPLIED AND, HENCE, PROCEEDED TO PERFORM THE FULL THICKNESS RESECTION. HOWEVER, CLIP APPLICATION WAS VISUALLY NOT VERIFIED BEFOREHAND. THE THEREFORE CAUSED PERFORATION WAS CLOSED BY SURGERY. AS REPORTED THE PATIENT RECOVERED UNEVENTFULLY.

  Patient problems: Bowel Perforation

  MAUDE report 14559140 ↗
• InjuryNov 10, 2021Activation Failure

  PATIENT WAS IN FOR COLONOSCOPY WITH ENDOSCOPIC ULTRASOUND AND POSSIBLE FULL THICKNESS RESECTION DEVICE (FTRD). LESION FOUND AND ASSESSED BY DOCTORS. THEY FELT IT NEEDED TO BE REMOVED VIA FTRD. AFTER PERFORMING CLIP PLACEMENT AND SNARING OF LESION IT WAS QUICKLY NOTED THAT THERE WAS A SIGMOID COLON PERFORATION. THE SCRUB TECH LOOKED AT THE FTRD SYSTEM THAT WAS REMOVED FROM THE SCOPE AND SAW THAT THE OVESCO CLIP DID NOT DEPLOY. SO, THE CLIP DID NOT GRAB THE TISSUE PRIOR TO SNARING AND CUTTING THE LESION. DOCTOR (WHO HAD PERFORMED FTRD) THEN DECIDED TO STITCH WITH X-TACK SUTURES. PATIENT'S BELLY BECAME SEVERELY DISTENDED AND VERESS NEEDLE HAD TO BE PLACED INTO THE ABDOMEN BY DOCTOR. DOCTOR WAS ABLE TO SUTURE THE PERFORATION, HOWEVER, PATIENT HAD TO BE ADMITTED. FTRD WAS ATTEMPTING TO BE USED TO CLOSE A LARGE DEFECT/HOLE IN THE MUCOSA AFTER A POLYPECTOMY. FOR SOME REASON CLIP THAT CLOSED THE GAP DID NOT ATTACH TO PATIENT AND THE DEFECT/HOLE WAS CLOSED WITH SUTURE INSTEAD. DEVICE RETAINED AND PLACED IN RED BIN. STAFF UNABLE TO TELL IF WAS DEVICE, USER OR ANATOMY .

  Patient problems: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation

  MAUDE report 12786495 ↗
• InjuryMar 1, 2019Use of Device Problem; Use of Device Problem

  WITHIN THE ENDOSCOPIC INTERVENTION FOR RESECTING A 2 CM FLAT POLYP IN THE SIGMOID COLON, A DIAGNOSTIC FTRD SET (OVESCO ENDOSCOPY USA, INC, (B)(4)) FOR ENDOSCOPIC FULL THICKNESS RESECTION (EFTR) WAS USED. IT WAS DESCRIBED THAT THE FTRD CLIP COULD BE SUCCESSFULLY DEPLOYED; THUS, THE PHYSICIAN PROCEEDED WITH THE FULL THICKNESS RESECTION, AS INTENDED. AFTER FULL THICKNESS RESECTION THE PHYSICIAN NOTICED THAT THE CLIP ADHERED TO THE OPPOSING COLONIC WALL AND ASSUMED IT WOULD CLOSE THE COLON LUMEN. OVESCO'S REMOVE SYSTEM WAS USED TO REMOVE THE FTRD CLIP WITH THE INTENTION TO GAIN MORE LUMINAL SPACE ALTHOUGH THIS WOULD LEAD TO OPENING OF THE BOWEL WALL. TO CLOSE THE RESULTING PERFORATION A OTSC CLIP (14/6T) WAS USED BUT THE CLIP COULD NOT BE APPLIED SINCE THE RELEASE HAND WHEEL DISLODGED. A SECOND OTSC CLIP (14/6T) COULD NOT BE APPLIED EITHER. IT WAS DESCRIBED THAT ONLY THE BOTTOM TEETH DEPLOYED BUT NOT THE TOP SET OF TEETH. A DIFFERENT CLIP TYPE FROM ANOTHER MANUFACTURER WAS THEN USED AND FIRST APPEARED TO CLOSE THE PERFORATION SUCCESSFULLY. BUT CONTRAST AGENT LEAKAGE INTO THE ABDOMINAL CAVITY WAS SEEN UPON FLUOROSCOPY. THUS, THE PATIENT TRANSFERRED TO PACU AND WAS TREATED BY SURGICAL SI

  Patient problems: Obstruction/Occlusion

  MAUDE report 8381582 ↗
• InjuryFeb 13, 2019Break; Leak/Splash; Failure to Advance; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  PATIENT PRESENTED TO THE ENDOSCOPY DEPARTMENT TO PLACE A FULL THICKNESS CLIP (FTRD) ON A POLYP IN THE SIGMOID COLON. PER PROCEDURAL NOTE (WHICH PERFECTLY SUMMARIZES THE EVENT: "WHEN THE CLIP WAS DEPLOYED, GI DID PROCEED WITH A FULL THICKNESS RESECTION, AND ATTEMPTED TO PLACE A FULL-THICKNESS CLOSURE DEVICE, UNFORTUNATELY THIS DEVICE ADHERED TO THE OPPOSING COLONIC WALL, THE DEVICE WAS REMOVED, AND A NEW DEVICE WAS PLACED (A PADLOCK), BUT THIS TOO ADHERED TO THE OPPOSING WALL AND WITH INJECTION OF CONTRAST MATERIAL THERE WAS NOTED TO BE A SMALL LEAK FROM THE FULL-THICKNESS RESECTION SITE. BECAUSE OF THIS, THE ENDOSCOPY TEAM DECIDED TO DISCONTINUE THE PROCEDURE, TAKE THE PATIENT OFF ANESTHESIA AND CONSULT GENERAL SURGERY FOR POSSIBLE SIGMOID COLON RESECTION." THE FTRD CLIP (SEE ATTACHED PICTURES) DID NOT CAUSE THE ISSUE-THE AREA WAS DIFFICULT TO ACCESS AND WHEN DEPLOYED, CLOSED THE COLON LUMEN COMPLETELY. THE OVESCO REPS WERE PRESENT AT THE BEDSIDE AND VERBALLY ASSISTED THE PROCESS). THE CLIP WAS SUCCESSFULLY REMOVED USING A OVESCO CLIP CUTTER AND A OVESCO CLIP 14/T WAS DEPLOYED TO CLOSE COLON PERFORATION-IT MALFUNCTIONED. A SECOND 14T WAS DEPLOYED AND AGAIN-MALFUNCTIONED. WRITER SUG

  Patient problems: Abdominal Distention; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8334797 ↗