RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF-T3 (UDI 04953170318214)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170318214), received between Dec 6, 2022 and Jan 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGOFIBERSCOPE EYEPIECE EXPERIENCED LEAKAGE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE CHANNEL TUBE CONTAINED FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564490 ↗
• MalfunctionDec 6, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE IMAGE IS NOT STABLE ON THE RHINO-LARYNGOFIBERSCOPE. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE RESIN PART OF THE IMAGE GUIDE HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923521 ↗