Olympus WA29042ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Ureteroscope, 8,6/9,8 Fr. x 430 mm, 7°, 6,4 Fr. channel, with WA00396A · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ureteroscope is a thin scope used to examine the urinary tract. The 25 reports that name its identifier mostly describe broken, bent or cracked scopes, including fractured bodies and damaged eyepieces, lenses and light-guide parts found during evaluation or maintenance, 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 04042761062503), received between Feb 24, 2023 and Feb 25, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Crack2
- Material Twisted/Bent2
- Connection Problem1
- Loose or Intermittent Connection1
- Poor Quality Image1
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.
MalfunctionFeb 25, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD DAMAGED EYEPIECE AND LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442200 ↗MalfunctionJan 21, 2026Break
IT WAS REPORTED THE SCOPE BODY OF RIGID SCOPE WAS FRACTURED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24140787 ↗MalfunctionDec 23, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE EXHIBITED THE FOLLOWING REPORTABLE EVENTS: A PART OF THE LIGHT GUIDE SECTION WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881508 ↗MalfunctionSep 10, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23016865 ↗MalfunctionJul 30, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THE RIGID URETEROSCOPE¿S LIGHT GUIDE CONNECTOR CAME OFF. THE ISSUE WAS FOUND DURING ROUTINE MAINTENANCE AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666902 ↗MalfunctionJun 10, 2025Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22179461 ↗MalfunctionJun 10, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A CROOKED SCOPE BODY AND COMPONENT FAILURE OF THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176204 ↗MalfunctionApr 28, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21919685 ↗MalfunctionApr 25, 2025Material Twisted/Bent; Material Twisted/Bent
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21911760 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A BROKEN FIBER IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21409794 ↗MalfunctionJan 27, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21248631 ↗MalfunctionOct 14, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE URETEROSCOPE FLUSH STOPCOCK OPENING/CLOSING HANDLE WAS LOOSE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20438976 ↗MalfunctionSep 6, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE RIGID URETEROSCOPE HAD A BROKEN TIP LENS (COVER GLASS). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157779 ↗MalfunctionAug 13, 2024Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE URETEROSCOPE LIGHT GUIDE END FACE WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977190 ↗MalfunctionJun 20, 2024Break; Break
IT WAS REPORTED THE RIGID URETEROSCOPE LENS WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19578430 ↗MalfunctionJun 6, 2024Crack; Crack
IT WAS REPORTED THE IMAGE OF THE RIGID URETEROSCOPE WAS CRACKED. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475501 ↗MalfunctionDec 6, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE OLYMPUS URETEROSCOPE HAD A BLACK BLUR IN THE CENTER OF THE SCREEN. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE GOLD-PLATED SECTION OF THE OUTER TUBE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18275255 ↗MalfunctionNov 29, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE URETEROSCOPE HAD A BROKEN DISTAL END. THE ISSUE WAS FOUND DURING REPROCESSING. THE INTENDED PROCEDURE BEING PERFORMED WAS A DIAGNOSTIC URETERAL TUBE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18233612 ↗MalfunctionNov 16, 2023Break; Break
THE CUSTOMER REPORTED THAT THE OUTER TUBE OF HIS OLYMPUS URETEROSCOPE WAS FOUND DAMAGED DURING PREPARATION FOR A DIAGNOSTIC PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THIS DID NOT CAUSE ANY DELAYS OR PATIENT HARM AS THE PATIENT WAS NOT YET UNDER ANESTHESIA. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18148221 ↗MalfunctionJul 17, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE URETEROSCOPE, HAS A BROKEN AND MISSING LIGHT GUIDE CONNECTOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17339235 ↗MalfunctionMay 1, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT THE URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A IMAGE IS DARK, AND THE INSERTION PART (OUTER TUBE) WAS BROKEN DURING REPROCESSING FOR AN UNKNOWN DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843737 ↗MalfunctionApr 26, 2023Break; Break
IT WAS REPORTED TO OLYMPUS, THAT A URETEROSCOPE HAD BREAKAGE OF THE EXTERIOR LIGHT GUIDE. THE REPORTED ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WAS NO DELAY IN THE PROCEDURE, AS IT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16820403 ↗MalfunctionApr 6, 2023Break; Break
THE CUSTOMER RIGID URETEROSCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR A REPORTED ¿IMAGE WITH CRACKS¿ FOUND DURING REPROCESSING. IT WAS REPORTED THE UROLITHIASIS PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT. UPON INSPECTING, THE FINGER REST AT THE INSERTION SECTION SIDE WAS FOUND BROKEN. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN FINGER REST FOUND DURING REPAIR INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16694315 ↗MalfunctionMar 30, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED TO OLYMPUS THAT A URETEROSCOPE WAS BENT, AND THE FRONT END WAS DAMAGED. THE REPORTED PROBLEM WAS FOUND DURING REPROCESSING BEFORE USE. THE FACILITY FINISHED THE PROCEDURE WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16649153 ↗MalfunctionFeb 24, 2023Break; Break
IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE WAS SENT IN FOR REPAIR. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16440776 ↗
Other Ureteroscope And Accessories, Flexible/Rigid devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall1,125 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls397 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall305 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls190 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls170 reports
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DOlympus Medical Systems Corp. · Ureteroscope And Accessories, Flexible/Rigid186 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall121 reports
- n.a. 091279-01Karl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid118 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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