Olympus WAIR530ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope ULTRA IR, 5.4 mm, 30° · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus telescope laparoscope is a slim rigid scope used in laparoscopic surgery. Reports mostly describe lenses chipping, breaking or detaching, along with peeling coating and loose parts found during device checks with no patient involvement. There are 26 adverse event reports that name its identifier, with 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
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04042761086189), received between Dec 5, 2022 and Apr 23, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
- Break11
- Detachment of Device or Device Component9
- Scratched Material2
- Connection Problem1
- Crack1
- Failure to Disconnect1
- Loose or Intermittent Connection1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CHIPPED LENSES IN THE OPTICAL SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965333 ↗MalfunctionApr 22, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED CHIPPED OPTICAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953882 ↗MalfunctionApr 17, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD PEELED GOLD PLATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24907476 ↗MalfunctionMar 23, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD DETACHED DISTAL END LENS AND ALSO IT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661828 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE EXHIBITED DETACHED LENS FROM DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24543305 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD LOOSE EYEPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251160 ↗MalfunctionJan 29, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID OPTICAL LAPAROSCOPE HAD BROKEN OPTICAL LENSES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24215408 ↗MalfunctionDec 15, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804933 ↗MalfunctionJun 4, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BROKEN INTERNAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22144912 ↗MalfunctionMay 15, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED INTERNAL LENS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026610 ↗MalfunctionApr 23, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD DARK IMAGE. THE ISSUE OCCURRED DURING SET UP FOR A DIAGNOSTIC LAPAROSCOPY. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21888376 ↗MalfunctionFeb 21, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD CRACKS ON THE LENS. THE ISSUE OCCURRED DURING A THERAPEUTIC VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) PARTIAL RESECTION. THE ISSUE 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 21436055 ↗MalfunctionFeb 18, 2025Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE TELESCOPE HAD THE ADAPTER LEFT AT THE END. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21402398 ↗MalfunctionJan 2, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21060463 ↗MalfunctionOct 28, 2024Crack; Crack
IT WAS REPORTED THE RIGID OPTICAL LAPAROSCOPE HAD A CRACK IN THE OUTER LENS. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543766 ↗MalfunctionSep 27, 2024Detachment of Device or Device Component; Scratched Material; Detachment of Device or Device Component; Scratched Material
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE EYEPIECE PART OF THE TELESCOPE WAS SCRATCHED, AND THE LIGHT GUIDE CONNECTOR PART WAS COMING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20328562 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TELESCOPE HAD THE EYEPIECE COME OFF. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236743 ↗MalfunctionMay 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE RIGID OPTICAL LAPAROSCOPE HAD A LOOSE EYEPIECE. THE ISSUE OCCURRED DURING A MAINTENANCE INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19249760 ↗MalfunctionMay 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TELESCOPE EXHIBITED A DAMAGED EYEPIECE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19240258 ↗MalfunctionApr 29, 2024Scratched Material; Scratched Material
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID OPTICAL LAPAROSCOPE EXHIBITED THE TIP SECTION COVER GLASS WAS SCRATCHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19203475 ↗MalfunctionDec 28, 2023Break; Break
AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER THAT THERE WAS A CRACK IN THE TELESCOPE. THE EVENT OCCURRED WITHIN THE OPERATING ROOM (OR) DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18409024 ↗MalfunctionNov 23, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "IR", 5.4 MM, 30° HAD LENS DAMAGE. THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE EVALUATION FOUND THE EYEPIECE COVER GLASS WAS CHIPPED. THERE WERE 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 18197132 ↗MalfunctionNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "IR", 5.4 MM, 30° HAD AN EYEPIECE THAT COMES OFF. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18052732 ↗MalfunctionSep 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT WHILE REPROCESSING HIS OLYMPUS IR TELESCOPE A CHIP WAS DISCOVERED IN THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17711083 ↗MalfunctionJul 25, 2023Connection Problem; Connection Problem
THE CUSTOMER REPORTED TO OLYMPUS THE TELESCOPE "IR", 5.4 MM, 30° L - SHAPE ADAPTER IS STUCK, AND THE LIGHT GUIDE CONNECTOR PART WILL NOT COME OFF. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17390203 ↗
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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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