Olympus WA29048ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04042761062510), received between Sep 24, 2021 and Jun 2, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Detachment of Device or Device Component

  THE CUSTOMER RETURNED THE URETEROSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD MISSING LIGHT GUIDE POST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365761 ↗
• MalfunctionSep 18, 2025Break; Unintended Movement; Break; Unintended Movement

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED LOOSE LOCKING MECHANISM AND CRACKED OBJECTIVE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085515 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT THE URETEROSCOPE HAD DAMAGE AT THE HEAD OF THE SCOPE, AND THE TOP BLACK EYEPIECE LENS SPOT WAS OFF. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566490 ↗
• MalfunctionMar 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL HAD A LOOSE INSERTION TUBE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18864677 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, THE EYEPIECE CAME OFF THE URETEROSCOPE. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481089 ↗
• MalfunctionJul 25, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING A URETEROSCOPE, THERE WAS A BROKEN PIECE. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390387 ↗
• InjurySep 24, 2021Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THE URETEROSCOPE TESTED POSITIVE FOR PSEUDOMONAS AFTER REPEATED STERILIZATIONS. THE CUSTOMER ALSO STATED A FEW (UNKNOWN NUMBER) PATIENTS WERE DIAGNOSED WITH PSEUDOMONAS AFTER A THERAPEUTIC URETEROSCOPY. THE PATIENTS WERE TREATED WITH ANTIBIOTICS AND RECOVERED. THE CUSTOMER ALSO STATED THE SCOPE INITIALLY TESTED NEGATIVE AND THEN TESTED POSITIVE AFTER BEING CULTURED AGAIN. IT IS UNKNOWN WHEN THE SCOPE TESTED NEGATIVE IN RELATION TO THE PATIENTS' PROCEDURES. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Bacterial Infection

  MAUDE report 12529654 ↗
• InjurySep 24, 2021Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THE URETEROSCOPE TESTED POSITIVE FOR PSEUDOMONAS AFTER REPEATED STERILIZATIONS. THE CUSTOMER ALSO STATED A FEW (UNKNOWN NUMBER) PATIENTS WERE DIAGNOSED WITH PSEUDOMONAS AFTER A THERAPEUTIC URETEROSCOPY. THE PATIENTS WERE TREATED WITH ANTIBIOTICS AND RECOVERED. THE CUSTOMER ALSO STATED THE SCOPE INITIALLY TESTED NEGATIVE AND THEN TESTED POSITIVE AFTER BEING CULTURED AGAIN. IT IS UNKNOWN WHEN THE SCOPE TESTED NEGATIVE IN RELATION TO THE PATIENTS' PROCEDURES. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Bacterial Infection

  MAUDE report 12529601 ↗