Olympus WA50013ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Quick summary
This Olympus rigid video laparoscope is a surgical scope used to view inside the abdomen. The 67 reports mostly describe image problems — blurry or poor quality pictures, no image at all, lines and spots on the screen — along with cracked, dented, or broken parts of the scope and light guide tube. No deaths and no injuries were reported. There are no recalls naming this device, and reports in the last 12 months (13) are down from 34 in the prior year.
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
- 67
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 04042761061957), received between Feb 27, 2024 and May 8, 2026 — classified as 67 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (37 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 Image37
- Break10
- Dent in Material8
- No Display/Image6
- Crack3
- Display or Visual Feedback Problem3
- Image Orientation Incorrect3
- Material Split, Cut or Torn3
Patient problems
- No Clinical Signs, Symptoms or Conditions67
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Erratic or Intermittent Display; Connection Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD NO IMAGE AND THE CONNECTION HAD TO BE REPEATEDLY ADJUSTED TO OBTAIN AN IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128878 ↗MalfunctionApr 22, 2026Poor Visibility
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A VISION ISSUE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954448 ↗MalfunctionApr 14, 2026Break; Poor Quality Image
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE RIGID VIDEO TELESCOPE EXHIBITED FAILURE OF THE VIDEO CONNECTOR, LIGHT SOURCE FUNCTION, AND LIGHT GUIDE BUNDLE, RESULTING IN A FAILED IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876238 ↗MalfunctionMar 30, 2026Poor Quality Image
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DISPLAYED LINES AND SPOTS IN THE IMAGE DURING SEDATION WITH THE DEVICE INSIDE THE PATIENT. THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24719214 ↗MalfunctionFeb 19, 2026Moisture Damage; Dent in Material
IT WAS OBSERVED DURING DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE HAD DENTED OUTER TUBE AND THERE WERE SIGNS OF WATER INGRESS ON THE LIGHT GUIDE ADAPTER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24393038 ↗MalfunctionFeb 11, 2026No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313708 ↗MalfunctionJan 30, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE, THE DISTAL END COVER GLASS FAILED ON ITS APPEARANCE TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225326 ↗MalfunctionJan 22, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED A NON-THREE-DIMENSIONAL IMAGE FUNCTION FAILURE DUE, TO A COMPONENT FAILURE OF AN ELECTRONIC COMPONENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24154331 ↗MalfunctionDec 31, 2025Image Orientation Incorrect; Image Orientation Incorrect
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD AN IMAGE ROTATION ISSUE. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23938694 ↗MalfunctionDec 30, 2025Break; Dent in Material; Break; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED A DAMAGED UNIVERSAL CORD AND CHIPPED LIGHT GUIDE BUNDLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927669 ↗MalfunctionDec 30, 2025Dent in Material; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPES HAD RIGID TUBE DENTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23921841 ↗MalfunctionNov 19, 2025Break; Poor Quality Image; Output Problem; Break; Poor Quality Image; Output Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED FAILURE OF LIGHT SOURCE (LIGHT TRANSMISSION ISSUE), ABNORMAL IMAGE, COMPONENT FAILURE OF LIGHT GUIDE BUNDLE AND ELECTRONICS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593220 ↗MalfunctionNov 13, 2025Scratched Material; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED SCRATCHES ON OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23547541 ↗MalfunctionOct 23, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE RIGID VIDEO SCOPE EXPERIENCED POOR IMAGE QUALITY (SANDSTORM) DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.;
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372009 ↗MalfunctionOct 23, 2025Break; Poor Quality Image; Break; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368587 ↗MalfunctionOct 22, 2025Circuit Failure; Poor Quality Image; Material Split, Cut or Torn; Circuit Failure; Poor Quality Image; Material Split, Cut or Torn
IT WAS REPORTED THAT THE SUBJECT DEVICE PRESENTED A MAGENTA LINE APPEARS ACROSS THE IMAGE, A DAMAGE ON CHARGED COUPLED DEVICE (CCD) CAMERA AND THE VIDEO CABLE HAD A CUT ON IT. THE ISSUE WAS FOUND DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360215 ↗MalfunctionOct 21, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE EXPERIENCED MOISTURE IN THE IMAGE. THIS ISSUE OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23350663 ↗MalfunctionOct 17, 2025Poor Quality Image; Material Integrity Problem; Poor Quality Image; Material Integrity Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323197 ↗MalfunctionOct 16, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312657 ↗MalfunctionOct 16, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23311535 ↗MalfunctionOct 15, 2025Poor Quality Image; Gas/Air Leak; Poor Quality Image; Gas/Air Leak
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295206 ↗MalfunctionSep 10, 2025Misfocusing; Misfocusing
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23018274 ↗MalfunctionAug 20, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22857023 ↗MalfunctionAug 20, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852346 ↗MalfunctionAug 7, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736858 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.