Olympus WAIR130ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Telescope IR 10 mm, 30° · Class 2
Quick summary
This Olympus WAIR130A is a rigid telescope used in laparoscopy. Most of the 66 reports describe the scope breaking or coming apart — cover glass and lens pieces detaching, chipped or cracked internal lenses, and peeling plating — often noticed during inspection or evaluation rather than during surgery. Two injuries and no deaths are reported, and no recalls name this device. Reports rose from 8 in the earlier 12-month period to 23 in the most recent one.
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
- 66
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04042761083638), received between Dec 26, 2022 and May 11, 2026 — classified as 2 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Break” (23 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
Most reported problems
Device problems
- Break23
- Detachment of Device or Device Component20
- Mechanical Problem3
- Adverse Event Without Identified Device or Use Problem2
- Loose or Intermittent Connection2
- Poor Quality Image2
- Scratched Material2
- Sharp Edges2
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Hemorrhage/Blood Loss/Bleeding2
- Bowel Perforation1
- Internal Organ Perforation1
- Perforation of Vessels1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD A BROKEN AND DETACHED COVER GLASS AT DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136117 ↗MalfunctionApr 30, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD DETACHMENT OF OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049600 ↗MalfunctionApr 16, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED PEELED OFF GOLD PLATING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899723 ↗MalfunctionApr 15, 2026Fracture; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887018 ↗MalfunctionApr 8, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE INTERNAL LENS DAMAGED (CHIPPED). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24819011 ↗MalfunctionApr 7, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD A CONNECTING RING ON THE LENS THAT CAME OFF. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796491 ↗MalfunctionApr 6, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED INTERNAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790353 ↗MalfunctionMar 30, 2026Poor Quality Image
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD NO IMAGE. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SAME DEVICE UNDER SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728542 ↗MalfunctionMar 25, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED CHIPPED DISTAL LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689128 ↗MalfunctionMar 23, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD CHIPPED LENS AND DISTAL END LENS WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661500 ↗MalfunctionFeb 27, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED A DAMAGED EYEPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468182 ↗MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT RIGID ENDOSCOPE TELESCOPE HAD TINY BIT OF DAMAGE ON THE SHAFT RIGHT AT THE DISTAL END. THE ISSUE WAS IDENTIFIED DURING DEVICE REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456356 ↗MalfunctionFeb 3, 2026Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD TIP COVER GLASS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251621 ↗MalfunctionFeb 3, 2026Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD SCRATCHES ON THE EYEPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251461 ↗MalfunctionFeb 3, 2026Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD SCRATCHES ON THE EYEPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251099 ↗MalfunctionFeb 2, 2026Break
IT WAS OBSERVED DURING DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE HAD DAMAGED LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24231782 ↗MalfunctionJan 21, 2026Unstable
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD LOOSE COVER RING. THE ISSUE WAS FOUND AFTER PROCEDURE - UPON COMPLETION OF PROCEDURE, DEVICE NO LONGER USED ON PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24132649 ↗MalfunctionJan 21, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131913 ↗MalfunctionJan 20, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED SCRATCHES ON THE EYEPIECE AND TIP COVER GLASS DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24121741 ↗MalfunctionDec 26, 2025Sharp Edges; Sharp Edges
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID ENDOSCOPE TELESCOPE EXHIBITED SHARP EDGES ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23896845 ↗MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID ENDOSCOPE TELESCOPE HAD COME OFF EYEPIECE PART. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769567 ↗MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INTERNAL OPTICAL LENS OF THE RIGID SCOPE DETACHED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696415 ↗MalfunctionNov 18, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TELESCOPE EXHIBITED LIGHT GUIDE LENS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584306 ↗MalfunctionOct 15, 2025Defective Component; Defective Component
IT WAS OBSERVED THAT DURING DEVICE EVALUATION THE SUBJECT DEVICE HAD EXHIBITED DISTAL END LENS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291504 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE EXPERIENCED BROKEN LENSES. THE ISSUE OCCURRED DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22719686 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.