Olympus WA50021BRecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus rigid video laparoscope is a surgical scope used in minimally invasive operations. The reports mostly describe damage found during cleaning or servicing: cracked, scratched or dented lens tips, broken fiber bundles, bent outer tubes, and images that come out blurry or blank, including one where the camera broke. All 54 reports are malfunctions with no patient involvement, and no deaths or injuries were reported. There are no recalls naming this device, and the report count stayed the same over the last12 months at 15.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04042761066815), received between Apr 17, 2024 and Jun 9, 2026 — classified as 54 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (19 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 Image19
- Dent in Material12
- Break10
- No Display/Image10
- Scratched Material7
- Crack6
- Display or Visual Feedback Problem4
- Material Twisted/Bent3
Patient problems
- No Clinical Signs, Symptoms or Conditions54
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Break; Poor Quality Image; Dent in Material; Scratched Material
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE EXHIBITED DISTAL FIBER BREAKAGE, DENTS AND SCRATCHES ON THE OBJECTIVE FRAME AT THE DISTAL END, AND AN IMAGE THAT WAS OUT OF FIELD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448456 ↗MalfunctionMay 8, 2026Poor Quality Image; Scratched Material; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD SCRATCHES ON OBJECTIVE LENS, HOLE ON LIGHT GUIDE CABLE AND DARK IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128143 ↗MalfunctionMay 5, 2026No Display/Image
IT WAS REPORTED THAT THE RIGID VIDEO SCOPE EXHIBITS NO IMAGE DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083547 ↗MalfunctionApr 11, 2026Dent in Material
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852572 ↗MalfunctionApr 7, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801065 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A BROKEN CAMARA. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776607 ↗MalfunctionApr 1, 2026Break; Dent in Material; Material Twisted/Bent
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE PRESENTED BREAKAGE OF DISTAL FIBERS, DENTS ON THE DISTAL EDGE AND BENT ON THE OUTER TUBE PROXIMAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753919 ↗MalfunctionMar 24, 2026Break; No Display/Image; Dent in Material; Material Twisted/Bent; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD FIBER BREAKAGE, DENTS ON THE DISTAL END, A BENT OUTER TUBE, SCRATCHES ON THE DISTAL END AND NO IMAGE WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24674170 ↗MalfunctionMar 23, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD DENTED DISTAL EDGE OF OUTER TUBE AND BROKEN DISTAL FIBER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661979 ↗MalfunctionMar 13, 2026Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590924 ↗MalfunctionMar 10, 2026Display or Visual Feedback Problem
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE HAD DIM LIGHT. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560573 ↗MalfunctionMar 6, 2026No Display/Image
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24534287 ↗MalfunctionFeb 26, 2026Poor Quality Image; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD DENT ON EDGE OF OBJECTIVE FRAME AND HORIZENTAL FLICKERING LINES ON IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454008 ↗MalfunctionFeb 10, 2026No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD NO SCREEN, HAD BLUE SCREEN AND GREEN LINES DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24306225 ↗MalfunctionJan 14, 2026Break; Crack; No Display/Image; Poor Quality Image; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD AN OUTER TUBE BENT, FIBER BREAKAGE, BIG DENT ON DISTAL EDGE, NO IMAGE AND IMAGE ONLY SHOW STATIC. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067577 ↗MalfunctionOct 30, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEOSCOPE EXHIBITED DISTAL END FIBERS BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23430027 ↗MalfunctionOct 15, 2025Poor Quality Image; Poor Quality Image
NO OTHER UPDATED INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292032 ↗MalfunctionSep 16, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD IMAGE ISSUE BLUE TENT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063868 ↗MalfunctionSep 14, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE'S LIGHT GRAY BUTTON KEEPS POPPING OFF. THE EVENT HAD OCCURRED DURING THE SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23047871 ↗MalfunctionSep 8, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22994128 ↗MalfunctionAug 13, 2025Dent in Material; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE PRODUCT EXHIBITED DENTS ON DISTAL EDGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22793742 ↗MalfunctionAug 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THE SUBJECT DEVICE HAD LEAK IN CORD. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22790591 ↗MalfunctionJul 24, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22594296 ↗MalfunctionMay 15, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THE SUBJECT DEVICE HAD A BUNCH OF BUBBLES IN THE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026095 ↗MalfunctionMay 5, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21959883 ↗
Other Laparoscope, General & Plastic Surgery devices
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- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
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- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
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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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