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Olympus WAIR500ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · Telescope ULTRA IR, 5.4 mm, 0° · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04042761086172), received between Jan 3, 2023 and May 6, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break6
  • Component Missing1
  • Detachment of Device or Device Component1
  • Material Fragmentation1
  • Scratched Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions9

Recent adverse event reports

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

  • MalfunctionMay 6, 2026Break

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CHIPPED LENS IN OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25098314 ↗
  • MalfunctionApr 22, 2026Material Fragmentation

    IT WAS REPORTED THAT THE RIGID OPTICAL LAPAROSCOPE HAD CHIP IN THE GLASS AT THE TIP OF THE SCOPE. THE ISSUE WAS FOUND DURING A REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24954771 ↗
  • MalfunctionFeb 3, 2026Scratched Material

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD SCRATCHES ON THE EYEPIECE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24251546 ↗
  • MalfunctionDec 23, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23882268 ↗
  • MalfunctionApr 24, 2025Break; Break

    IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A BROKEN ROD LENS. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21902603 ↗
  • MalfunctionSep 3, 2024Break; Break

    IT WAS REPORTED THE TELESCOPE HAD A CHIP IN THE TIP OF THE SCOPE. THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20125001 ↗
  • MalfunctionFeb 26, 2024Component Missing; Component Missing

    IT WAS REPORTED, THE ULTRA IR TELESCOPE HAD A LIGHT POST THAT IS MISSING FROM THE SCOPE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18777628 ↗
  • MalfunctionFeb 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    OLYMPUS WAS INFORMED BY THE INSTRUMENT SPECIALIST AT THE USER FACILITY, THE AUTOCLAVABLE RIGID TELESCOPE ¿LIGHT POST WAS DISCONNECTED FROM THE SCOPE AT THE END OF THE PROCEDURE/NURSE MANAGER BROKEN OFF LIGHT POST FROM SCOPE¿. THE REPORTED PROBLEM WAS FOUND DURING REPROCESSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16394998 ↗
  • MalfunctionJan 3, 2023Break; Break

    THE CUSTOMER REPORTED THE ROD LENS OF THE SUBJECT DEVICE FOUND TO BE POSSIBLY BROKEN DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16090260 ↗

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Sources and updates

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