Olympus WA29040ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Ureteroscope, 6,4/7,8 Fr. x 430 mm, 7°, 4,2 Fr. channel, with WA00395A · Class 2
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04042761062497), received between Apr 12, 2023 and Feb 12, 2026 — classified as 1 injury, 21 malfunctions.
The most frequently reported specific device problem is “Break” (11 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
- Break11
- Loose or Intermittent Connection3
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Detachment of Device or Device Component1
- Excessive Heating1
- Fracture1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Fever1
- Urinary Tract Infection1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Break
IT WAS REPORTED THAT THE RIGID URETEROSCOPE HAD A CHIPPED LENS ON THE OBJECTIVE WINDOW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24324079 ↗MalfunctionFeb 12, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID URETEROSCOPE HAD DAMAGED TIP COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321984 ↗MalfunctionFeb 5, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24271139 ↗MalfunctionJan 14, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED GOLD PLATING OF INSERTION TUBE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067785 ↗MalfunctionJul 28, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN FIBERS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22638987 ↗MalfunctionMay 16, 2025Material Deformation; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED AN OUT-OF-RANGE EYEPIECE CAP TILT ADJUSTMENT VALUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036557 ↗MalfunctionMay 13, 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 22012508 ↗MalfunctionApr 16, 2025Fracture; Fracture
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE DISTAL TIP CRACKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21852677 ↗MalfunctionMar 7, 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 21551941 ↗MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID SCOPE EXHIBITED OUTER TUBE DEFECT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405695 ↗MalfunctionOct 24, 2024Excessive Heating; Excessive Heating
IT WAS REPORTED THE URETEROSCOPE HAS BURNT TIP DAMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20522761 ↗MalfunctionOct 7, 2024Break; Break
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID URETEROSCOPE'S OUTER TUBE WAS BENT AND BROKEN. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383091 ↗MalfunctionJul 11, 2024Break; Break
IT WAS REPORTED THE URETEROSCOPE HAD BROKEN LENS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720098 ↗MalfunctionApr 30, 2024Break; Break
IT WAS REPORTED THE RIGID URETEROSCOPE'S TIP WAS CHIPPED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19213678 ↗MalfunctionApr 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID URETEROSCOPE EXHIBITED A DETACHED EYEPIECE COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19087375 ↗MalfunctionMar 13, 2024Scratched Material; Scratched Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, 4,2 FR. CHANNEL, WITH WA00395A EXHIBITED A SCRATCH AND HORIZONTAL LINE AT THE BOTTOM CENTER OF THE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895196 ↗MalfunctionFeb 5, 2024Break; Break
IT WAS REPORTED, THE RIGID URETEROSCOPE'S LIGHT GUIDE CONNECTION LENS WAS BURNT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18640235 ↗MalfunctionDec 21, 2023Crack; Crack
THE CUSTOMER REPORTED TO OLYMPUS, THE URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, 4,2 FR. CHANNEL, WITH WA00395A HAD A CRACK IN THE CAMERA HEAD CONNECTION. THE ISSUE WAS FOUND DURING REPROCESSING FOR A THERAPEUTIC PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18372907 ↗InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "QUALITY OF LIFE AFTER URINARY STONE SURGERY BASED ON JAPANESE WISCONSIN STONE QUALITY OF LIFE QUESTIONNAIRE: MULTICENTER ANALYSIS FROM SMART STUDY GROUP." WE AIMED TO EVALUATE THE IMPACT OF SURGICAL TREATMENT FOR URINARY STONES ON PERIOPERATIVE HEALTH-RELATED QUALITY OF LIFE (HRQOL) USING THE JAPANESE WISCONSIN STONE QUALITY OF LIFE QUESTIONNAIRE (J-WISQOL), AN HRQOL MEASURE DESIGNED FOR PATIENTS WITH URINARY STONES. THIS STUDY PROSPECTIVELY ENROLLED 123 PATIENTS WITH URINARY STONES WHO VISITED THREE ACADEMIC HOSPITALS FOR STONE TREATMENT. THE PARTICIPANTS COMPLETED THE J-WISQOL WITHIN 4 WEEKS BEFORE AND AFTER THE URINARY STONE TREATMENT. TREATMENTS INCLUDED SHOCK WAVE LITHOTRIPSY (SWL), URETEROSCOPY LITHOTRIPSY, AND ENDOSCOPIC COMBINED INTRARENAL SURGERY. J-WISQOL WAS ASSESSED FOR AGE, STONE SIZE AND LOCATION, TYPE OF TREATMENT, STONE-FREE STATUS, POSTOPERATIVE URETERAL STENT PLACEMENT, HOSPITAL STAY, AND COMPLICATIONS IN ALL PATIENTS. PATIENTS WITH STONES IN THE URETER HAD SIGNIFICANTLY GREATER SOCIAL IMPACT D1 AND DISEASE IMPACT D3 THAN THOSE WITH STONES IN THE KIDNEY. IN A COMPARISON OF PRE- AND POSTOPERATIVE J-WISQOL, PATIENTS
Patient problems: Fever; Urinary Tract Infection
MAUDE report 18165542 ↗MalfunctionSep 19, 2023Break; Break
THE CUSTOMER REPORTED THAT SCOPES OBJECTIVE LENS WAS CRACKED. THE ISSUE WAS FOUND DURING MAINTENANCE INSPECTION. THERE WAS NO PATIENT OR PROCEDURE INVOLVED. THERE WERE NO REPORTS OF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17775769 ↗MalfunctionAug 10, 2023Break; Break
AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, THE URETEROSCOPE HAD FINGER BREAKAGE. THERE WAS NO REPORT OF USER OR PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17497549 ↗MalfunctionApr 12, 2023Break; Break
THE URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, 4,2 FR. CHANNEL, WAS RETURNED AND EVALUATED. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND A CHIPPED TIP. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16728679 ↗
Other Ureteroscope And Accessories, Flexible/Rigid devices
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.