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
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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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