Olympus WA29049ARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04042761063043), received between Jan 6, 2023 and Apr 6, 2026 — classified as 17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED CHIPPED OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24788481 ↗
• MalfunctionFeb 26, 2026Loose or Intermittent Connection

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE HAD LOOSE LOCKING MECHANISM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457324 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE PRESENTED MISSING GOLD PLATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24440228 ↗
• MalfunctionFeb 16, 2026Loose or Intermittent Connection

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE HAD A LOOSE COLOR RING ON THE OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24347868 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE URETEROSCOPE EXHIBITED AN EXITED SYSTEM TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303095 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905280 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155322 ↗
• MalfunctionApr 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880155 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THE SUBJECT DEVICE HAD A BROKEN HANDLE DURING REPROCESSING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060582 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED, THE URETEROSCOPE, 6,4/7,8 FR. X 330 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL DISPLAYED A BROKEN EYE PIECE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019315 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED, THE URETEROSCOPE HAD BROKEN AND DEFORMED/BENT COMPONENTS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18600219 ↗
• MalfunctionDec 18, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE URETEROSCOPE, 6,4/7,8 FR. X 330 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL HAD A BENT SHAFT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352002 ↗
• MalfunctionOct 5, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS, AT THE OUTPATIENT SURGERY UNIT, DURING PROCEDURE, IT WAS REPORTED THAT THE DEVICE-URETEROSCOPE, 6,4/7,8 FR. X 330 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL, WITH WA00395A WAS BENT AT THE END OF THE PROCEDURE WHEN REMOVING THE SCOPE. THE PROCEDURE WAS URETEROSCOPY LASER LITHOTRIPSY STENTING UNDERTAKEN AND COMPLETED WITH THE SAME DEVICE. THE PROCEDURE WAS PROLONGED BY 15 MINS. THOUGH THERE WAS A DELAY, THIS DELAY WAS REPORTED TO BE A SHORT ONE. THERE WERE NO REPORTS OF PATIENT HARM OR CLINICAL IMPACT ASSOCIATED WITH THE REPORTED EVENT. NO MEDICAL INTERVENTION WAS UNDERTAKEN TO PRECLUDE PERMANENT HARM/INJURY TO THE PATIENT. THERE IS NO EVIDENCE OF ANY SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT. ALSO, NO INDICATION OF ANY LIFE-THREATENING EVENT OCCURRED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875829 ↗
• MalfunctionFeb 28, 2023Break; Break

  OLYMPUS WAS INFORMED VIA REPAIR REQUEST, THE CUSTOMER STRAIGHT OCULAR ANGLE AUTOCLAVABLE RIGID URETEROSCOPE ¿IS BROKEN IN HALF¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT REPROCESSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454632 ↗
• MalfunctionFeb 1, 2023Break; Break

  OLYMPUS WAS INFORMED THAT THE CUSTOMER STRAIGHT OCULAR ANGLE AUTOCLAVABLE URETEROSCOPE HAS A BROKEN OFF COMPONENT DEFECT, ¿THE LIGHT POST IS MISSING¿. THE CUSTOMER REPORTED EVENT WAS FOUND AT AN UNKNOWN EVENT. 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 16276092 ↗
• MalfunctionJan 26, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE URETEROSCOPE, 6,4/7,8 FR. X 330 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL, WITH WA00395A, WAS FOUND TO BE BENT. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE IT WAS OBSERVED, THE OUTER TUBE WAS BROKEN AND BROKEN BLACK PIECE WAS NOTED ON THE CHANNEL MECHANISM. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250427 ↗
• MalfunctionJan 6, 2023Break; Break

  THE ONSITE SUPPORT SPECIALIST REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, THE CUSTOMER STRAIGHT OCULAR ANGLE, DUAL CHANNEL SEMI-RIGID URETEROSCOPE HAS A REPORTED BROKEN COMPONENT DEFECT, ¿DAMAGED LENS¿. IT WAS REPORTED THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR SCOPE. NO DEATH INJURY OR INFECTION AND NO IMPACT TO PERSON OR OTHER WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118227 ↗