Olympus WA2UR11ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ureteroscope is a rigid scope for examining the urinary tract. The 23 reports mostly describe parts breaking or coming loose, such as broken tips and irrigation ports and detached tips or lenses, often noticed during inspection or maintenance, with no deaths and no injuries mentioned. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04042761086387), received between Jan 11, 2023 and Sep 28, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Detachment of Device or Device Component7
- Material Protrusion/Extrusion2
- Component Missing1
- Loose or Intermittent Connection1
- Material Fragmentation1
- Poor Quality Image1
- Thermal Decomposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Protrusion/Extrusion
The customer reported that the tip was coming out during an inspection for use involving an Olympus rigid ureteroscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917873 ↗MalfunctionFeb 26, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD BROKEN IRRIGATION PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454995 ↗MalfunctionFeb 19, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD LOOSE STOPCOCK HANDLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24386130 ↗MalfunctionFeb 10, 2026Component Missing
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24305960 ↗MalfunctionFeb 3, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID URETEROSCOPE HAD THE DISTAL TIP DETACHED FROM THE OUTER TUBE. THE ISSUE WAS FOUND DURING SEDATION FOR A DIAGNOSTIC STENT REMOVAL PROCEDURE THAT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245941 ↗MalfunctionJan 29, 2026Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24216719 ↗MalfunctionJan 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE OUTER LENS OF RIGID URETEROSCOPE CAME OUT. THE ISSUE WAS IDENTIFIED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092908 ↗MalfunctionNov 12, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THE SUBJECT DEVICE HAS A BROKEN TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, AS THE EVENT WAS REPORTED DURING EQUIPMENT INSPECTION, BEFORE THE PATIENT ENTERED THE ROOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534202 ↗MalfunctionSep 3, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A PROTRUSION OF THE LENS. THE ISSUE WAS FOUND DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22959854 ↗MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID SCOPE LENS SEEN OUTSIDE BEAK OF SCOPE (OUTER LENS COMES OUT). THE ISSUE OCCURRED DURING SERVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894287 ↗MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED STOP COCK IS DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202427 ↗MalfunctionJun 10, 2025Break; Break
NO ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22178844 ↗MalfunctionJan 6, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078486 ↗MalfunctionDec 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE URETEROSCOPE'S DISTAL END HAD BEEN BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20868465 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED THE SUBJECT DEVICE PIECE OF THE HANDLE BROKE OFF. THE ISSUE OCCURRED DURING A INSPECTION FOR USE FOR A THERAPEUTIC SEMI-REGIDE URS PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20859335 ↗MalfunctionNov 5, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE URETEROSCOPE EXHIBITED A DAMAGED STOP COCK. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20606959 ↗MalfunctionOct 9, 2024Break; Poor Quality Image; Break; Poor Quality Image
IT WAS REPORTED THE URETEROSCOPE DISTAL TIP BROKE OFF AND THE VISION WAS BLURRY. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407179 ↗MalfunctionSep 26, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID OPTICAL URETEROSCOPE'S STOCK COCK WAS BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20309755 ↗MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THAT THE DISTAL END OF THE URETEROSCOPE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280812 ↗MalfunctionSep 20, 2024Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD A DISTAL END BROKEN OF THE URS SCOPE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20267707 ↗MalfunctionJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIDGID SCOPE LIGHT GUIDE CONNECTION LOOSE / CONNECTOR PART DETACHED. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19816256 ↗MalfunctionDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS THAT THE URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 4.2 FR. CHANNEL TIP LOOKED DISPLACED. THE EVENT OCCURRED DURING A THERAPEUTIC LOWER URETERIC STONE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18354279 ↗MalfunctionOct 15, 2023Break; Break
THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE URETEROSCOPE DISTAL TIP BROKE OFF AND HAD AND VISION BLUR. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17936929 ↗MalfunctionJan 11, 2023Break; Break
OLYMPUS WAS INFORMED THAT THE CUSTOMER ANGLED OCULAR SEMI-RIGID URETEROSCOPE WAS RETURNED TO THE OLYMPUS SERVICE CENTER FOR A REPORTED ¿STOPCOCK IS BROKEN¿. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT PREPARATION FOR USE. HOWEVER, THE SERVICE INSPECTION IDENTIFIED THE ENTIRE STOP COCK VALVE WAS BROKEN OFF AND MISSING. NO DEATH OR INJURY AND NO IMPACT TO PERSON OR OTHER WAS REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE BROKEN OFF COMPONENT FOUND DURING SERVICE INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16139229 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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