Olympus WA2UR22ARecalls & 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 31 reports describe the scope breaking — often at the tip or cover glass, or the outer tube — usually noticed during cleaning or evaluation, with one report of a kidney infection. There are 30 malfunctions,1 injury and no deaths, and 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
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04042761086424), received between Jan 12, 2023 and Aug 21, 2026 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Break” (23 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
- Break23
- Crack2
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Fracture1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Kidney Infection1
- Unspecified Kidney or Urinary Problem1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50376286 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358876 ↗MalfunctionApr 25, 2026Break
IT WAS REPORTED THAT THE URETEROSCOPE WAS BROKEN AT THE TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24991648 ↗MalfunctionApr 23, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED BROKEN COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965868 ↗MalfunctionFeb 25, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24446185 ↗MalfunctionFeb 9, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETROSCOPE EXHIBITED AN EXITED SYSTEM TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290920 ↗MalfunctionFeb 9, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE URETEROSCOPE HAD A BROKEN OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290164 ↗MalfunctionDec 4, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED BROKEN COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717423 ↗MalfunctionOct 15, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301936 ↗MalfunctionSep 16, 2025Break; Crack; Material Twisted/Bent; Break; Crack; Material Twisted/Bent
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BENT/ CRACK/ BROKEN, SHEATH. THE EVENT OCCURRED DURING THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23067206 ↗MalfunctionAug 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED THE DISTAL END AND BROKEN OUTER TUBE .THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22687842 ↗MalfunctionJul 31, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS SHATTERED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22680604 ↗MalfunctionJul 14, 2025Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED THAT THE DISTAL FIBER OF THE OBJECT WINDOW WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22502971 ↗MalfunctionJul 14, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD BROKEN DISTAL TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22497487 ↗MalfunctionJun 11, 2025Break; Break
IT WAS REPORTED THE TIP OF THE SUBJECT DEVICE WAS BROKEN. THE ISSUE WAS IDENTIFIED DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22184909 ↗MalfunctionJun 11, 2025Break; Break
IT WAS REPORTED THE TIP OF THE SUBJECT DEVICE BROKE DURING SEDATION FOR A THERAPEUTIC LITHOTRIPSY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183569 ↗MalfunctionMay 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING REPROCESSING OF THE DEVICE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089358 ↗MalfunctionMay 2, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED BROKEN TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951698 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT THE RIGID SCOPE HAD A BROKEN TIP. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO REPORT OF ANY PATIENT HARM OR INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880715 ↗MalfunctionMar 28, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN LENS. THIS ISSUE OCCURRED DURING UNSPECIFIED PROCEDURE USING SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21721861 ↗MalfunctionMar 26, 2025Break; Break
IT WAS REPORTED THE TIP OF SUBJECT DEVICE WAS BROKEN DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21695139 ↗MalfunctionFeb 21, 2025Material Fragmentation; Material Fragmentation
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21433847 ↗MalfunctionJan 22, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE IS CLOUDY AND THE SCOPE¿S BENT. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21210979 ↗MalfunctionSep 4, 2024Break; Defective Component; Break; Defective Component
IT WAS REPORTED, THE URETEROSCOPE HAD A BROKEN OR DEFECTIVE OR DAMAGED COMPONENTS. SEVERELY BENT AT 45-DEGREE ANGLE TOWARDS DISTAL TIP. THE ISSUE OCCURRED, DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140775 ↗MalfunctionAug 7, 2024Break; Break
IT WAS REPORTED THE UTEROSCOPE HAD A CRACKED HANDLE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19928781 ↗
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.