Olympus WA29041ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Ureteroscope, 6,4/7,8 Fr. x 330 mm, 7°, 4,2 Fr. channel, with WA00395A · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04042761063036), received between Jun 6, 2023 and Mar 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Component Missing
IT WAS REPORTED THAT THE RIGID URETEROSCOPE WAS FOUND TO HAVE A MISSING LENS DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729309 ↗MalfunctionApr 3, 2024Break; Break
IT WAS REPORTED, THE URETEROSCOPE, 6,4/7,8 FR. X 330 MM, 7°, 4,2 FR. CHANNEL, WITH WA00395A EXHIBITED A BROKEN COMPONENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19033497 ↗MalfunctionJun 6, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE URETEROSCOPE HAD A BROKEN PLASTIC ATTACHMENT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17075180 ↗
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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