RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF-T3 (UDI 04953170307188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170307188), received between Jul 12, 2022 and Sep 16, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0332-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Corroded

  The customer returned the Rhino Laryngofiberscope to the service center for a separate issue. During the device analysis, it was indicated that a corroded distal end was found. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791172 ↗
• MalfunctionAug 26, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455667 ↗
• MalfunctionAug 10, 2026Device Reprocessing Problem

  The customer returned the rhino-laryngofiberscope to the service center for a separate issue. During the device analysis, It was indicated that dirt deposition in the bending section cover and connecting tube was found. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195863 ↗
• MalfunctionJul 1, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THAT DUE TO CLOGGING OF THE CHANNEL TUBE (FOREIGN OBJECT), THE TUBE CLEANING BRUSH CANNOT BE INSERTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378313 ↗
• MalfunctionNov 7, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED FOREIGN OBJECTS ON THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629972 ↗
• MalfunctionApr 24, 2024Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED THE RHINO-LARYNGOFIBERSCOPE WAS STERILIZED, BUT WAS OVERLOADED WITH BACTERIA. THE ISSUE WAS FOUND WHEN PREPARING THE DEVICE FOR USE IN A DIAGNOSTIC CANNULOSCOPY PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174174 ↗
• MalfunctionJan 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE RHINO-LARYNGO-SCOPE HAD HOLES IN THE INSERTION SECTION AND AN ELONGATED ANGLE WIRE. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING DEVICE EVALUATION, FOREIGN MATERIAL WAS FOUND IN THE CHANNEL. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466742 ↗
• MalfunctionJan 20, 2023Break; Break

  ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: THE ISSUE WAS FOUND DURING REPROCESSING AND THE INTENDED PROCEDURE WAS PERFORMED WITH A SIMILAR DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216355 ↗
• InjuryJul 12, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE COATING ON THE INSERTION TUBE OF THE SUBJECT DEVICE WAS TORN OFF, AND THE PATIENT SWALLOWED THE PEELED OFF MATERIAL. THE INTENDED PROCEDURE WAS COMPLETED USING THE SUBJECT DEVICE. THE WAS NO IMPACT ON THE PATIENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988044 ↗