Olympus WA2UR21ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04042761086417), received between Sep 13, 2023 and Apr 15, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Crack1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE HAD DAMAGED OBJECTIVE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24884241 ↗MalfunctionFeb 9, 2026Break
IT WAS REPORTED THAT THE URETEROSCOPE HAD PART WHERE THE LIGHT GUIDE CABLE CONNECTS IS BROKEN. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290175 ↗MalfunctionJun 3, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD EXHIBITED DISTAL END WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132177 ↗MalfunctionDec 30, 2024Crack; Crack
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036974 ↗MalfunctionSep 25, 2023Break; Break
THE PROCEDURE, A LASER URETEROSCOPY, WAS FOR A STONE RUPTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17814526 ↗MalfunctionSep 13, 2023Melted; Melted
AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THE TIP OF URETEROSCOPE 6.9/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 3.7 FR. AND 2.6 FR. CHANNEL WAS MELTED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741095 ↗
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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