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FTRD System Set 14Recalls & reported problems

Ovesco Endoscopy AG · The FTRD System 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 instruments: FTRD System (application cap with preloaded clip and integrated HF snare) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD System 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 System) · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260206310556), received between Jun 14, 2018 and Nov 13, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Activation, Positioning or Separation Problem1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • Internal Organ Perforation1
  • Patient Problem/Medical Problem1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 13, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    WITHIN THE ENDOSCOPIC INTERVENTION OF A NON-LIFTING LESION, LOCATED AT THE APPENDICEAL ORIFICE, A FTRD SYSTEM FOR ENDOSCOPIC FULL THICKNESS RESECTION (EFTRD) WAS USED IN ORDER TO SAVE THE PATIENT FROM SURGERY IN THE FIRST PLACE. IT WAS DESCRIBED, THAT THE TISSUE WAS INCREDIBLY STIFF AND FIBROTIC AND THEREFORE NOT EASY TO PULL INTO THE FTRD CAP. CLIP WAS THEN ATTEMPTED FOR DEPLOYMENT. THE WHITE RING, WHICH IS USED FOR CLIP DEPLOYMENT AND BY WHICH CORRECT CLIP DEPLOYMENT CAN BE CONTROLLED BY USER, ADVANCED DOWN TOWARDS THE END OF THE CAP BUT WAS STILL VISIBLE. THE CLIP DISAPPEARED FROM ENDOSCOPIC VIEW. ALL PERSONS PRESENT (PHYSICIAN, TECHNICIAN AND NURSE) AGREED THAT THE CLIP APPEARED TO BE DEPLOYED. THE SNARE WAS THEN CLOSED AND TISSUE RESECTED. UPON REMOVAL OF THE SCOPE, IT WAS NOTICED THAT THE CLIP WAS STILL HANGING ONTO THE EDGE OF THE CAP. IN THE SAME MOMENT THEY NOTICED THE CLIP, THE CLIP RELEASED. ASSESSMENT OF THE SITE SHOWED A PERFORATION AND PATIENT WAS TRANSITIONED TO LAPAROSCOPIC SURGERY.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 8064005 ↗
  • InjuryJun 14, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

    WITHIN THE ENDOSCOPIC TREATMENT OF A FLAT POLY AT THE TRANSVERSE COLON, A FTRD SYSTEM SET WAS USED. THE USER DID NOT DEPLOY THE CLIP AND STARTED RESECTIONING WITH THE HF-SNARE (CLIP AND SNARE ARE BOTH INTEGRATED PARTS OF THE FTRD SYSTEM), RESULTING IN A COLON PERFORATION. THE PATIENT WENT IMMEDIATELY TO SURGERY FOR A LAPAROTOMY WHERE THE PERFORATION WAS CLOSED. THE PATIENT IS DOING FINE.

    Patient problems: Internal Organ Perforation

    MAUDE report 7600290 ↗

Other Endoscopic Grasping/Cutting Instrument, Non-Powered devices

All Endoscopic Grasping/Cutting Instrument, Non-Powered devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.