RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 (UDI 04953170402456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170402456), received between Jan 18, 2023 and May 8, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS EMPLOYEE REPORTED THAT THE RHINO-LARYNGO VIDEOSCOPE HAD BUCKLING OF THE LIGHT GUIDE CORRUGATED TUBE PROTECTOR. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE LIGHT GUIDE LENS WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT AND 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 16887499 ↗
• MalfunctionJan 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE RHINO-LARYNGO VIDEOSCOPE, HAD AIR/WATER FLOW ISSUES. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. DURING DEVICE EVALUATION AT OLYMPUS, THE ILLUMINATION LENS AND PLASTIC DISTAL END COVER HAD FALLEN OFF. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195126 ↗