Olympus WA2UR23ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Quick summary
This Olympus flexible ureteroscope is a thin scope used to look inside the urinary tract. Most of the 36 reports describe the scope breaking — tips snapping off, outer tubes cracking or splitting into pieces, and covers detaching — sometimes noticed during inspection before use, and a few during procedures. Two injuries and no deaths were reported. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 04042761086431), received between Jun 30, 2023 and Feb 27, 2026 — classified as 2 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Break” (25 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
- Break25
- Detachment of Device or Device Component4
- Crack2
- Material Twisted/Bent2
- Poor Quality Image2
- Degraded1
- Device Reprocessing Problem1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE URETEROSCOPE TIP BROKE OFF DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475019 ↗MalfunctionFeb 24, 2026Break
IT WAS OBSERVED DURING DEVICE EVALUATION, THE URETEROSCOPE HAD SUNKED TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24430434 ↗MalfunctionFeb 23, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE HAD BROKEN OBJECTIVE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24414421 ↗MalfunctionFeb 19, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED BROKEN OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387618 ↗MalfunctionFeb 17, 2026Break
ADDITIONAL ISSUES FOUND DURING INVESTIGATION WERE DETERMINED TO BE NOT REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363482 ↗MalfunctionFeb 4, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED DETACHED DISTAL END AND THE OUTER TUBE WAS BROKEN INTO TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264278 ↗MalfunctionFeb 2, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE HAD BROKEN OFF OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24232265 ↗MalfunctionJan 9, 2026Break
IT WAS REPORTED THAT THE URETEROSCOPE HAD A BROKEN DISTAL TIP. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020688 ↗MalfunctionNov 3, 2025Degraded; Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED FIBER BREAKAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460045 ↗MalfunctionOct 20, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337448 ↗MalfunctionSep 16, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN DISTAL TIP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23062873 ↗MalfunctionJun 20, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE SUBJECT DEVICE BURNED AT THE TIP WHERE THE CHANNEL IS LOCATED. THIS ISSUE OCCURRED DURING THE REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22297103 ↗MalfunctionJun 13, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202650 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE END OF LENS WAS BROKEN. THE ISSUE OCCURRED DURING INSPECTION FOR USE BEFORE THE PATIENT ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143709 ↗MalfunctionMar 28, 2025Break; Break
IT WAS REPORTED THAT THE BLACK PLASTIC HANDLE OF THE SUBJECT DEVICE WAS BROKEN. THE ISSUE WAS IDENTIFIED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21726291 ↗MalfunctionMar 28, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN LENS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21719775 ↗MalfunctionFeb 3, 2025Break; Break
IT WAS REPORTED; THE SUBJECT DEVICE BROKE IN HALF (0.4 INCHES) FROM THE DISTAL TIP. THE ISSUE OCCURRED AFTER COMPLETION OF A THERAPEUTIC URETEROSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21293888 ↗MalfunctionDec 30, 2024Break; Break
IT WAS REPORTED THE URETEROSCOPE WAS FOUND BROKEN DURING INSPECTION FOR USE, PRIOR TO PATIENT IN ROOM FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21036921 ↗MalfunctionDec 12, 2024Break; Break
IT WAS REPORTED THAT AFTER A THERAPEUTIC URETEROSCOPY PROCEDURE, THE SUBJECT DEVICE HAD BROKEN IN HALF ABOUT FOUR INCHES FROM THE DISTAL TIP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913681 ↗MalfunctionDec 10, 2024Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20893453 ↗InjuryDec 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT WHILE USING A SEMI-RIGID URETEROSCOPE DURING A CYSTOSCOPY, THE END BROKE OFF WHILE INSIDE THE PATIENT'S URETHRA. THE END DETACHED AND FELL INSIDE THE URETHRA, BUT IT CAME OUT WHEN THE SCOPE WAS REMOVED. THE URETHRA WAS VISUALIZED USING A SECOND SCOPE AND THERE WERE NO SIGNS OF INJURY. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20845564 ↗InjuryDec 4, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE WHILE USING A SEMI-RIGID URETEROSCOPE DURING A CYSTOSCOPY, THE END BROKE OFF WHILE INSIDE THE PATIENT'S URETHRA. THE END DETACHED AND FELL INSIDE THE URETHRA, BUT IT CAME OUT WHEN THE SCOPE WAS REMOVED. THE URETHRA WAS VISUALIZED USING A SECOND SCOPE AND THERE WERE NO SIGNS OF INJURY. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20845463 ↗MalfunctionOct 29, 2024Break; Break
IT WAS REPORTED, THE UTETEROSCOPE'S TIP HAD FOUR INCHES BREAK OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20558304 ↗MalfunctionOct 23, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE URETEROSCOPE HAD DAMAGED DISTAL END. AS REPORTED, THE SCOPE WAS FOUND TO BE BROKEN DURING CLEANING BY THE STERILE PROCESSING DEPARTMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514089 ↗MalfunctionJun 17, 2024Crack; Crack
IT WAS REPORTED THE URETEROSCOPE HAD A CRACKED LENS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19546662 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.