Pathfinder® Endoscope Overtube GI 110140-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850006222087), received between Dec 30, 2024 and Dec 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Off-Label Use; Off-Label Use

  A PATIENT WAS ADMITTED FOR COLONOSCOPY TO REMOVE A FOREIGN BODY THAT HAD MIGRATED TO THE DISTAL COLON. THE MD DETERMINED THAT THE DEVICE WOULD BE A USEFUL TOOL TO HELP WITH THE REMOVAL OF THE FOREIGN BODY, AND REQUESTED THE OVERTUBE FOR THE PROCEDURE. UPON EXAMINATION OF THE DEVICE BY THE PHYSICIAN PERFORMING THE PROCEDURE, THE PHYSICIAN ASKED THAT THE DISTAL TIP (TAPERED PORTION) OF THE DEVICE BE TRIMMED TO CREATE A LARGER WORKING CHANNEL. AT THE REQUEST OF THE MD, A COMPANY EMPLOYEE TRIMMED THE DISTAL TIP USING SCISSORS. THE DEVICE WAS INSERTED INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE DEVICE IS A HOLLOW TUBE FOR USE OVER A FLEXIBLE GASTROINTESTINAL ENDOSCOPE. THE ENDOSCOPE IS INSERTED THROUGH THE PROXIMAL END OF THE DEVICE AND COMES OUT THE DISTAL END. THE DISTAL TIP IS A TAPERED, ATRAUMATIC SILICONE TIP THAT IS ATTACHED TO THE DISTAL END OF PATHFINDER. PER INTERNAL DOCUMENTATION, THE POTENTIAL HARM IN THE EVENT THE ATRAUMATIC TIP IS LOST AND THE DEVICE IS INSERTED INTO THE PATIENT IS GI TRACT DAMAGE UP TO AND INCLUDING PERFORATION OF PATIENT ANATOMY REQUIRING SURGICAL INTERVENTION. THERE WAS NO REPORTED ADVERSE EVENT OR HARM OCCURRING IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036387 ↗