MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, 4,2 FR. CHANNEL, WITH WA00395A; RIGID URETEROSCOPE

Model Number	WA29040A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additional information: h3, h4, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported event is likely due to the effect of a large mechanical force due to a shock, fall or collision with other equipment.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, 4,2 FR. CHANNEL, WITH WA00395A
• Common Device Name: RIGID URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20383091
• Report Number: 9610773-2024-02441
• Device Sequence Number: 6566307
• Product Code: FGB
• UDI-Device Identifier: 04042761062497
• UDI-Public: 04042761062497
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: Other
• Device Model Number: WA29040A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2019
• Is the Device Labeled for Single Use? (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