MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A; RIGID URETEROSCOPE

Model Number	WA29042A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter establishment name: (b)(6) hospital.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the subject device had distal end cover glass damaged.The issue was identified during device inspection before use.There were no reports of patient harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to a previously submitted report.The event "distal end cover glass damaged" was reported in error, and it would be unlikely to cause or contribute to a death or a serious injury if it were to recur.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A
• Common Device Name: RIGID URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23016865
• Report Number: 9610773-2025-05719
• Device Sequence Number: 9573532
• Product Code: FGB
• UDI-Device Identifier: 04042761062503
• UDI-Public: 04042761062503
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA29042A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown