Olympus WA02946ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Ureteroscope, 7,5 Fr. x 330 mm, 7°, 2 channels, straight ocular angle · Class 2
Quick summary
This Olympus ureteroscope is a rigid scope for viewing inside the ureter. The 23 reports mostly describe physical damage found during checks or cleaning, such as breaks, bends, loose rings and cracked or broken glass and lenses, 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
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04042761029940), received between Dec 1, 2022 and Feb 23, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Material Twisted/Bent3
- Detachment of Device or Device Component2
- Failure to Clean Adequately2
- Crack1
- Loose or Intermittent Connection1
- Material Integrity Problem1
- Misconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD A LOOSE MODEL RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413136 ↗MalfunctionFeb 19, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD BROKEN COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388124 ↗MalfunctionFeb 17, 2026Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD LOOSE MODEL RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370165 ↗MalfunctionDec 4, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715708 ↗MalfunctionNov 27, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665962 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS BENT AND BROKEN. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441856 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD BROKEN LENS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030227 ↗MalfunctionMay 7, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED AN END BURNED BY A LASER DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21981531 ↗MalfunctionMar 23, 2025Break; Break
IT WAS REPORTED THAT THE FLEXIBLE SCOPE BRUSH OF THE SUBJECT DEVICE HAD BROKEN OFF. THE ISSUE WAS DISCOVERED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21673586 ↗MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21599807 ↗MalfunctionNov 22, 2024Break; Break
IT WAS REPORTED, THAT 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 20759678 ↗MalfunctionOct 9, 2024Misconnection; Misconnection
THE CUSTOMER REPORTED THAT WHILE REPROCESSING HER OLYMPUS URETEROSCOPE, THE STOPCOCK PORT COULD NOT BE SCREWED BACK ONTO THE PORT. ACCORDING TO THE INITIAL REPORTER, THE PORT WAS CROSS THREADED. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20407137 ↗MalfunctionSep 27, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE URETEROSCOPE HAD A BENT SHAFT. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20324923 ↗MalfunctionSep 23, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THE UTETEROSCOPE'S CHANNEL WAS BLOCKED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20279017 ↗MalfunctionSep 5, 2024Break; Failure to Clean Adequately; Break; Failure to Clean Adequately
IT WAS REPORTED, THE URETEROSCOPE, 7,5 FR. X 330 MM, 7°, 2 CHANNELS, STRAIGHT OCULAR ANGLE CLEANING BRUSH BROKE OFF. AND WAS STUCK INSIDE THE PORT WITH FOREIGN MATERIAL. THE ISSUE OCCURRED, DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20146336 ↗MalfunctionJun 13, 2024Break; Break
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RIGID URETEROSCOPE HAD BROKEN PAN GLASS AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19530210 ↗MalfunctionMar 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED, THE RIGID URETEROSCOPE COLLAR WAS SLIDING BACK AND FORTH. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895041 ↗MalfunctionFeb 22, 2024Break; Break
IT WAS REPORTED, THAT THE URETEROSCOPE WAS BENT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18763855 ↗MalfunctionFeb 20, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE RIGID URETEROSCOPE WAS BENT AND WAS UNABLE TO PASS GRASPERS THROUGH THE CHANNEL. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18741241 ↗MalfunctionAug 30, 2023Break; Break
A USER FACILITY REPORTED TO OLYMPUS URETEROSCOPE, 7,5 FR. X 330 MM, 7°, 2 CHANNELS, STRAIGHT OCULAR ANGLE HAD A BROKEN LENS. THE MALFUNCTION WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM FOR THE UNIDENTIFIED DIAGNOSTIC PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17652597 ↗MalfunctionAug 3, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE URETEROSCOPE, HAD BROKEN PLAN GLASS AT THE TUBE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17447825 ↗MalfunctionJan 14, 2023Crack; Crack
IT WAS REPORTED TO OLYMPUS, THAT THE AUTOCLAVABLE URETEROSCOPE HAD A CRACKED LENS. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16169843 ↗MalfunctionDec 1, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent
OLYMPUS WAS INFORMED VIA SERVICE REQUEST BY THE STERILE PROCESSING MANAGER AT THE USER FACILITY THAT DURING REPROCESSING, THE CUSTOMER DUAL CHANNEL SEMI-RIGID URETEROSCOPE REPORTEDLY WAS FOUND TO HAVE ¿BROKEN ROD LENS AND THE SHAFT IS BENT¿. NO DEATH, INJURY, OR HARM TO THE PATIENT OR OTHER WAS REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15895835 ↗
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.