Olympus WA50011ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus laparoscope accessory is used with video endoscopy systems. The 23 reports mostly describe physical damage such as dents, cracks and breaks and poor or dim images, often noticed during inspection or servicing, 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04042761061728), received between Mar 9, 2023 and Sep 22, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (8 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
- Poor Quality Image8
- Break4
- Dent in Material4
- Crack2
- Detachment of Device or Device Component2
- Leak/Splash2
- Material Deformation2
- Communication or Transmission Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break; Poor Quality Image; Dent in Material; Scratched Material
The customer reported a black shadow in the upper right corner and side of the viewing area involving an Olympus Laparoscopes, Video. Additionally, during the initial evaluation of the device, fiber breakage, dents, and scratches on the distal frame, and dents and scratches on the outer tube were observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857098 ↗MalfunctionSep 14, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763285 ↗MalfunctionAug 4, 2026Break; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131974 ↗MalfunctionJun 5, 2026Crack
THE CUSTOMER REPORTED A CRACKED LIGHT SOURCE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414171 ↗MalfunctionApr 23, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LAPAROSCOPES, VIDEO PRESENTED MISSING ADAPTOR AND CUT IN THE LIGHT GUIDE CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966411 ↗MalfunctionFeb 25, 2026Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LAPAROSCOPES VIDEO SCOPES HAD DENTS ON THE DISTAL EDGE AND OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442913 ↗MalfunctionFeb 11, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315589 ↗MalfunctionJan 2, 2026Crack; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEO TELESCOPE EXHIBITED DENTS AND BENT ON OUTER TUBE, CRACK ON LEFT SIDE OF VIDEO CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23949769 ↗MalfunctionJul 16, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCE DISTURBANCE OF VIDEO IMAGE. THIS WAS DISCOVERED DURING SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22524622 ↗MalfunctionJun 25, 2025Optical Problem; Optical Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A DIM LIGHT. THE ISSUE OCCURRED DURING SEDATION (DEVICE OUTSIDE PATIENT) OF AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329471 ↗MalfunctionJun 4, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD POOR IMAGE QUALITY. THE ISSUE WAS FOUND 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 22147158 ↗MalfunctionApr 29, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD DISTURBANCE OF VIDEO IMAGE. THE ISSUE WAS FOUND DURING MAINTENANCE OF DEVICE. THERE ARE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925246 ↗MalfunctionApr 28, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING SETUP/INSPECTION FOR USE, THE RIGID VIDEO SCOPE DISPLAYED INCOMPATIBLE SCOPE ERROR E315. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21918198 ↗MalfunctionMar 6, 2025Dent in Material; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DENTED RIGID TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21536088 ↗MalfunctionFeb 7, 2025Dent in Material; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO SCOPE HAD A DENT IN INSERTION TUBE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334860 ↗MalfunctionOct 28, 2024Dent in Material; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT RIGID VIDEO SCOPE EXHIBITED MINOR DENTS ON THE DISTAL EDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20544563 ↗MalfunctionSep 4, 2024Electrical Shorting; Electrical Shorting
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A SHORT IN THE WIRE. THERE WERE NO REPORTS OF PATIENT HARM. NO HARM WAS REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20141076 ↗MalfunctionJul 26, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD AIR LEAKAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839850 ↗MalfunctionJul 25, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED DURING REPROCESSING, THE VIDEO SCOPE HAD A BUBBLE COMING OUT WHEN THEY WERE LOOKING AT IT, IT HAD A LEAK. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19828369 ↗MalfunctionMay 22, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING PREPARATION FOR A LAPAROSCOPY PROCEDURE, THE SUBJECT DEVICE IMAGE WAS IN AND OUT INTERMITTENTLY. THE PROCEDURE WAS COMPLETED UTILIZING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19371768 ↗MalfunctionMay 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THAT THE IMAGE IS DARK ON THE RIGID VIDEO SCOPE. THE ISSUE WAS FOUND, DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19287858 ↗MalfunctionApr 18, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE RIGID VIDEO SCOPE DISPLAYED A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT. EVENT DESCRIPTION-SCOPE IS BLURRY CUTOVER Y/N-Y WHEN DURING PROCEDURE DID EVENT OCCUR?-UNKNOWN ^09.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19133527 ↗MalfunctionAug 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS, THE OPERATION BUTTON DETACHED FROM THE VIDEO TELESCOPE. THE ISSUE WAS FOUND DURING REPROCESSING. THE INTENDED PROCEDURE WAS AN UNKNOWN THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17645749 ↗MalfunctionJun 23, 2023Break; Break
THE CUSTOMER RETURNED THE VIDEO TELESCOPE "ENDOEYE", TO OLYMPUS REPAIR CENTER FOR EVALUATION OF A REPORTED DAMAGED CABLE. DURING THE EVALUATION, DAMAGED COVER GLASS, AND A BROKEN LIGHT GUIDE BUNDLE WERE DETECTED. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE DAMAGED COVER GLASS, AND A BROKEN LIGHT GUIDE BUNDLE DEFECTS FOUND DURING THE REPAIR EVALUATION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17193889 ↗MalfunctionMar 9, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE AUTOCLAVABLE VIDEO TELESCOPE HAD A BROKEN LIGHT. NO PATIENT WAS INVOLVED IN THIS EVENT AND THE PLANNED PROCEDURE WAS THERAPEUTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16518749 ↗
Other Endoscope, Accessories, Narrow Band Spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 reports
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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