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Olympus WA96200ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Telescope, 4 mm, 0°, connector for light guide on bottom, autoclavable · Class 2

Quick summary

This Olympus nasopharyngoscope is a rigid scope used to look inside the nose and throat. The 25 reports mostly describe physical damage such as broken tips, shattered or cracked lenses and loose parts, found during maintenance or inspection without patient involvement. The reports mention no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
25
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04042761070027), received between Dec 28, 2022 and Jul 29, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 1 reportsJul 2024: 2 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break18
  • Crack2
  • Detachment of Device or Device Component2
  • Material Integrity Problem2
  • Connection Problem1
  • Mechanical Problem1
  • Pitted1
  • Poor Quality Image1

Patient problems

  • No Clinical Signs, Symptoms or Conditions25

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 29, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50077081 ↗
  • MalfunctionApr 29, 2026Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID RHINOSCOPE HAD A SHATTERED OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25028894 ↗
  • MalfunctionApr 14, 2026Break

    IT WAS REPORTED THAT THE RIGID RHINOSCOPE EXHIBITED A BROKEN DISTAL END DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24877941 ↗
  • MalfunctionFeb 23, 2026Break

    IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE RIGID RHINOSCOPE OUTER TUBE WAS DAMAGED AT THE DISTAL END, WITH PARTS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24418729 ↗
  • MalfunctionFeb 23, 2026Break; Detachment of Device or Device Component

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE HAD A LOOSE AND BROKEN MENISCUS. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24412767 ↗
  • MalfunctionDec 22, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23863185 ↗
  • MalfunctionDec 2, 2025Crack; Crack

    IT WAS REPORTED THE RIGID RHINOSCOPE HAD CRACKED GLASS DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23693313 ↗
  • MalfunctionOct 24, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23383943 ↗
  • MalfunctionJul 10, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THE RIGID SCOPE LOOKED LIKE IT HAD FALLEN TO THE FLOOR AND THE EDGE WAS KIND OF SHARP, IT IS NOT SMOOTH ANYMORE. THE EVENT OCCURRED DURING A DIAGNOSTIC LARYNGOSCOPY. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22475819 ↗
  • MalfunctionJul 2, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THE RIGID SCOPE IT IS NOT SMOOTH ANYMORE. THE EVENT OCCURRED DURING A THERAPEUTIC LARYNGOSCOPY WITH NO SEDATION. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22388740 ↗
  • MalfunctionFeb 26, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21469362 ↗
  • MalfunctionFeb 3, 2025Break; Break

    IT WAS REPORTED THE SUBJECT DEVICE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21300179 ↗
  • MalfunctionAug 7, 2024Pitted; Pitted

    IT WAS REPORTED, THE TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE DISPLAYED A CHIPPED TIP. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19928808 ↗
  • MalfunctionJul 16, 2024Break; Break

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TELESCOPE LIGHT GUIDE CONNECTION IS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19757730 ↗
  • MalfunctionJul 5, 2024Break; Break

    IT WAS OBSERVED DURING THE DEVICE EVALUATION, THAT THE TIP COVER GLASS OF THE TELESCOPE WAS BROKEN ON THE ENTIRE SURFACE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19684723 ↗
  • MalfunctionJun 3, 2024Break; Break

    IT WAS REPORTED, THE TELESCOPE'S TIP WAS BROKEN. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM AND THE INTENDED PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED WITH A SIMILAR DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19450965 ↗
  • MalfunctionMay 23, 2024Break; Break

    IT WAS REPORTED THAT THE RIGID RHINOSCOPE'S OPTICAL SYSTEM GLASS WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19383595 ↗
  • MalfunctionMay 8, 2024Break; Break

    IT WAS REPORTED THE ISSUE WAS FOUND DURING REPROCESSING. THE DEVICE DROPS OFF WHEN THE CUSTOMER WAS CLEANING IT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19269244 ↗
  • MalfunctionDec 5, 2023Connection Problem; Connection Problem

    THE CUSTOMER REPORTED THAT DURING PROCEDURE PREPARATION, HE NOTICED THAT THE LOOP PART OF HIS OLYMPUS AUTOCLAVABLE 4MM TELESCOPE WAS DISTORTED. SO, HE STOPPED USING THAT DEVICE, AND CONTINUED/COMPLETED THE INTENDED PROCEDURE USING A SIMILAR UNIT. THE CUSTOMER WENT ON TO CONFIRM THERE WERE NO HEALTH RISK ASSOCIATED WITH THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE LIGHT GUIDE CONNECTOR WAS DAMAGED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE CONFIRMED DAMAGED TO THE LIGHT GUIDE CONNECTOR NOTED DURING THE DEVICE EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18265936 ↗
  • MalfunctionAug 22, 2023Crack; Crack

    THE CUSTOMER REPORTED THAT WHEN USING A TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE, THE TIP WAS CRACKED. THE EVENT OCCURRED DURING PREPARATION FOR USE. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PROCEDURAL DELAY, OR NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17600496 ↗
  • MalfunctionAug 22, 2023Break; Break

    THE CUSTOMER REPORTED THAT THE GLASS WAS BROKEN INSIDE THE TUBE OF A TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17598464 ↗
  • MalfunctionJun 1, 2023Break; Break

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING MAINTENANCE THEY DISCOVERED THAT THE LENS WAS SHATTERED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17039332 ↗
  • MalfunctionMar 10, 2023Break; Poor Quality Image; Break; Poor Quality Image

    IT WAS REPORTED THAT THE DEVICE HAS BROKEN COMPONENTS AND THE SCREEN ON THE TIP OF THE SCOPE IS CRACKED. THE USER CANNOT SEE A CLEAR IMAGE. NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16526940 ↗
  • MalfunctionJan 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    OLYMPUS (OMSC) WAS INFORMED VIA REPAIR REQUEST THAT THE CUSTOMER AUTOCLAVABLE RIGID TELESCOPE HAS TIP DAMAGE AND ¿DETACHMENT OF LIGHT GUIDE CONNECTOR¿. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT AN UNSPECIFIED EVENT. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN OFF COMPONENT DEFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16225465 ↗
  • MalfunctionDec 28, 2022Mechanical Problem; Mechanical Problem

    AN OLYMPUS REPRESENTATIVE REPORTED THAT THE LENS OF THE TELESCOPE WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16058358 ↗

Other Nasopharyngoscope (Flexible Or Rigid) devices

All Nasopharyngoscope (Flexible Or Rigid) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.