RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VT3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170399640), received between Feb 1, 2022 and Jun 21, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K183416); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED THE RHINO-LARYNGO VIDEOSCOPE HAD GREEN WATER COMING OUT OF THE FORCEPS MOUTH. THE CUSTOMER NOTED THE SCOPE LEAKED WHEN BEING DRIED AFTER WASHING. THE ISSUE WAS FOUND WHEN PREPARING THE SCOPE FOR USE IN A THERAPEUTIC PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171033 ↗
• MalfunctionNov 6, 2022Noise, Audible; Noise, Audible

  A USER FACILITY REPORTED THAT THE RHINO-LARYNGO VIDEOSCOPE SCREEN IS BLACK. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, RATTLING FORCEPS CAP WAS NOTED. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15741312 ↗
• MalfunctionFeb 1, 2022Break; Scratched Material; Break; Scratched Material

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THE BENDING PART WAS CUT ON THE VISERA RHINO-LARYNGOVIDEOSCOPE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO SURGICAL DELAY. NO PATIENT HARM REPORTED. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED THE ANGLE COULD NOT BE CONTROLLED AND COULD NOT BE STRAIGHTENED DUE TO BREAKAGE OF THE ANGLE WIRE. ADDITIONALLY NOTED WERE SCRATCHES ON THE OBJECTIVE LENS AND A BROKEN BENDING SECTION COVER. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTIONS OF THE ANGLE COULD NOT BE CONTROLLED AND COULD NOT BE STRAIGHTENED DUE TO BREAKAGE OF THE ANGLE WIRE, SCRATCHES ON THE OBJECTIVE LENS, AND A BROKEN BENDING SECTION COVER NOTED AT ESTIMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13414546 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183416. One submission often covers many models, so check the product and lot details in each record.

• Z-0332-2024 · Sep 25, 2023 · Open, Classified
  Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-V