Olympus WA50023BRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus rigid video laparoscope is used for surgery in the abdomen. The 44 reports mostly describe image problems — poor or distorted pictures, no image at all, or an upside-down view — along with cracks, breaks and dents in the scope body found during inspection. None of the reports involve a death or an injury. 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
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 04042761066501), received between Jan 20, 2024 and May 6, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (17 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
- Poor Quality Image17
- No Display/Image8
- Crack6
- Break5
- Dent in Material5
- Communication or Transmission Problem2
- Failure to Clean Adequately2
- Image Orientation Incorrect2
Patient problems
- No Clinical Signs, Symptoms or Conditions44
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Poor Quality Image
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A CRACKED IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25095228 ↗MalfunctionApr 30, 2026Poor Quality Image; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED DEBRIS UNDER OBJECTIVE LENS, DUST REFLECTION IN IMAGE AND DISTORTED IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050276 ↗MalfunctionMar 31, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD ERROR CODE E311 DISPLAYED. THE ISSUE WAS FOUND DURING SEDATION - DEVICE OUTSIDE PATIENT - TO A THERAPEUTIC LAPAROSCOPIC APPENDECTOMY PROCEDURE THAT 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 24743786 ↗MalfunctionMar 5, 2026Poor Quality Image
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE RIGID VIDEO LAPAROSCOPE IMAGE WAS UPSIDE DOWN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519703 ↗MalfunctionMar 2, 2026Poor Quality Image; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED DIRT IN OBJECTIVE LENS AND IMAGE OUT OF FIELD OF VIEW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490525 ↗MalfunctionFeb 27, 2026Degraded; Dent in Material; Gas/Air Leak; Physical Resistance/Sticking
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD A HANDLE LEAK, A STUCK HANDLE RUBBER BAND, DENTS ON THE DISTAL EDGE, AND DAMAGED EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469669 ↗MalfunctionFeb 13, 2026Communication or Transmission Problem; Optical Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331995 ↗MalfunctionJan 9, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24021347 ↗MalfunctionDec 26, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE EXHIBITED A DARK IMAGE AND POOR VIEW DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898794 ↗MalfunctionDec 8, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FORM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23750806 ↗MalfunctionDec 4, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717615 ↗MalfunctionOct 21, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351133 ↗MalfunctionOct 16, 2025Leak/Splash; Leak/Splash
NO OTHER UPDATED INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310553 ↗MalfunctionJun 24, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD IMAGE PROBLEM. THE EVENT WAS REPORTED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22323343 ↗MalfunctionMay 23, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081061 ↗MalfunctionApr 25, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE HAD AN IMAGE NOT CLEAR DURING SETUP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21912131 ↗MalfunctionApr 24, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21905046 ↗MalfunctionMar 31, 2025Crack; Crack
IT WAS REPORTED THE LENS OF SUBJECT DEVICE WAS CRACKED NEAR ADAPTOR END. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729217 ↗MalfunctionMar 26, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21697135 ↗MalfunctionMar 26, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BUBBLES COMING FROM CORD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21696023 ↗MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LIGHT GUIDE TIP OF THE SUBJECT DEVICE CAME OFF. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21437032 ↗MalfunctionFeb 12, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THE RIGID VIDEO SCOPE HAD POOR IMAGE QUALITY AND THAT THERE WAS A BLACKOUT. THE ISSUE WAS FOUND DURING SET UP IN THE ROOM/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21368281 ↗MalfunctionJan 23, 2025Break; Poor Quality Image; Break; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD POOR IMAGE DUE TO BROKEN DISTAL END LENS. THE EVENT OCCURRED DURING SET UP/ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223149 ↗MalfunctionJan 14, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO PICTURE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21155113 ↗MalfunctionNov 27, 2024Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO TELESCOPE EXHIBITED DISTAL FIBER BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20791465 ↗
Other Laparoscope, General & Plastic Surgery devices
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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