Olympus WA02944ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Ureteroscope, 7,5 Fr. x 430 mm, 7°, 2 channels, straight ocular angle · Class 2
Quick summary
This is an Olympus rigid ureteroscope, a thin scope used to examine the urinary tract, with two channels for instruments. The 25 reports mostly describe parts of the scope breaking, cracking, bending, or coming loose, usually discovered during inspection or reprocessing rather than during patient care. One injury and no deaths are linked to these reports. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04042761029544), received between Nov 25, 2020 and Feb 16, 2026 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Break” (12 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
- Break12
- Material Twisted/Bent5
- Detachment of Device or Device Component4
- Crack2
- Device Reprocessing Problem1
- Loose or Intermittent Connection1
- Mechanical Problem1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD A MISSING OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343297 ↗MalfunctionFeb 10, 2026Loose or Intermittent Connection
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE EXHIBITED LOOSE SYSTEM TUBE EXITING FROM THE DISTAL FRAME. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309870 ↗MalfunctionJan 6, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE WAS RECEIVED WITHOUT THE INNER OUTER LIGHT GUIDE ADAPTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23977986 ↗MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A PLASTIC PIECE BROKEN OFF OF IT. THE ISSUE WAS FOUND DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23063044 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED BROKE BRUSH OFF IN THE SIDE CHANNEL. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21964466 ↗MalfunctionApr 30, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD THE TEST BROKE OFF ON THE INSIDE. THE ISSUE WAS FOUND DURING REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932970 ↗MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN BRUSH INSIDE IT. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21855582 ↗MalfunctionFeb 25, 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 21463862 ↗MalfunctionDec 30, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE URETEROSCOPE HAD A BENT WITH BROKEN LIGHT FIBERS. THIS ISSUE PROLONGED THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS THEN COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21037462 ↗InjuryDec 30, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE URETEROSCOPE HAD A BENT WITH BROKEN LIGHT FIBERS. THIS ISSUE PROLONGED THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS THEN COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21037122 ↗MalfunctionNov 29, 2024Crack; Crack
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD CRACKED SCOPE. THE ISSUE WAS FOUND DURING SEDATION FOR THERAPEUTIC CYSTOURETEROSCOPY PROCEDURE THAT WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20810961 ↗MalfunctionSep 4, 2024Crack; Crack
IT WAS REPORTED THE URETEROSCOPE HAD A CRACKED 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 20135147 ↗MalfunctionAug 21, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED, THE RIGID URETEROSCOPE WAS BADLY BENT. IT IS NOT KNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20010145 ↗MalfunctionJun 27, 2024Break; Break
IT WAS REPORTED THAT THE RIGID URETEROSCOPE HAD TOO MANY BROKEN FIBERS. THE ISSUE OCCURRED DURING A THERAPEUTIC URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19627333 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT ONE OF THE PLASTIC PIECES ON THE OUTSIDE OF THE RIGID URETEROSCOPE HAD BROKEN OFF AND LEFT A JAGGED PART. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19487089 ↗MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THE URETEROSCOPE HAD A BENT SHEATH THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19279685 ↗MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RIGID OPTICAL URETEROSCOPE HAD BROKEN COMPONENTS. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC, UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19269208 ↗MalfunctionApr 22, 2024Break; Break
IT WAS REPORTED THE URETEROSCOPE WAS BENT. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19154274 ↗MalfunctionAug 16, 2023Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE URETEROSCOPE WAS BENT. THE MALFUNCTION WAS IDENTIFIED DURING PREPARATION FOR USE. THE DIAGNOSTIC PROCEDURE (UTEREROSCOPY) 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 17557207 ↗MalfunctionJun 16, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THAT THE FIBER ON 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 17147906 ↗MalfunctionApr 16, 2023Mechanical Problem; Mechanical Problem
COMPANY REPRESENTATIVE REPORTED WITH ISSUE OF "BENT" . THE PROBLEM FOUND AT PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED ISSUE. NO HARM WAS REPORTED, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16748761 ↗MalfunctionFeb 16, 2023Poor Quality Image; Poor Quality Image
THE CUSTOMER REPORTED THAT, DURING REPROCESSING, THE IMAGE FROM THE SUBJECT DEVICE WAS POOR. THE SUBJECT DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, THE PLAN GLASS AT THE DISTAL END WAS DAMAGED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BROKEN COMPONENT). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16385116 ↗MalfunctionFeb 3, 2023Break; Break
THE OLYMPUS SALES REPRESENTATIVE REPORTED THE CUSTOMER STRAIGHT OCULAR AUTOCLAVABLE RIGID URETEROSOPE HAS A ¿BROKEN CHANNEL PORT¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT PREPARATION FOR USE. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16294422 ↗MalfunctionJan 4, 2023Break; Break
OLYMPUS WAS INFORMED THAT THE CUSTOMER DUAL CHANNEL STRAIGHT OCULAR ANGLE URETEROSCOPE HAS A BROKEN COMPONENT DEFECT, ¿BROKEN LENS¿. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT PROCEDURE. NO DEATH INJURY OR INFECTION AND NO PERSON OR OTHER WAS IMPACTED HAS BEEN REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16099385 ↗MalfunctionNov 25, 2020Device Reprocessing Problem; Device Reprocessing Problem
IT IS REPORTED FOLLOWING CLEANING AND STERILIZATION OF AN OLYMPUS URETEROSCOPE, DURING USE ON THE NEXT UNSPECIFIED PROCEDURE, A STONE WAS PUSHED OUT OF THE SCOPE FROM THE PREVIOUS PROCEDURE, AND INTO THE PATIENT. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10900438 ↗
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.