OLYMPUS OLYMPUS ENF-T3Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170411076), received between Feb 16, 2023 and Apr 20, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (3 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FLEXIBLE SCOPE EXHIBITED A FOREIGN BODY ON THE ADHESIVE OF THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149921 ↗
• MalfunctionMar 26, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED FOREIGN OBJECT ON THE ACTUATOR BODY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980011 ↗
• MalfunctionJan 16, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGOFIBERSCOPE HAD A CLOUDY IMAGE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE OBJECTIVE LENS AND LIGHT GUIDE LENS HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. 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 18522213 ↗
• MalfunctionDec 4, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGOFIBERSCOPE HAD COATING PEELING OFF AT THE TIP OF THE SCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE RESIN PART OF THE IMAGE GUIDE FLEXIBLE PIPE HAS 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 18263740 ↗
• MalfunctionOct 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE RHINO-LARYNGOFIBERSCOPE HAD PEELING OF THE OUTER SURFACE OF THE INSERTION PART. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE RESIN PART OF THE IMAGE GUIDE FLEXIBLE PIPE HAS 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 17862050 ↗
• MalfunctionFeb 16, 2023Disconnection; Disconnection

  THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGOFIBERSCOPE HAD DEFECTS ON THE INSERTION TUBE-NON BENDING SECTION. THE INTENDED PROCEDURE WAS A BIOPSY OF A LARYNGEAL TUMOR. THE PROCEDURE WAS COMPLETED. THE CUSTOMER USES THE SUBJECT DEVICE ONE TIME PER MONTH. THE CUSTOMER USES PHTHALAL FOR CLEANING, DISINFECTION, AND STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386570 ↗