MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 4.2 FR. CHANNEL; RIGID OPTICAL URETEROSCOPE

Model Number	WA2UR11A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the rigid optical ureteroscope's stock cock was broken.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.New information added to the following field(s): h6.The device was returned for evaluation where the reported event was identified.Based on the results of the investigation, a definitive root cause cannot be identified.The reported fault descriptions are most likely due to the effect of a large mechanical force due to a shock, fall or collision with other equipment.A device history review revealed no issues that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.

• Brand Name: URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 4.2 FR. CHANNEL
• Common Device Name: RIGID OPTICAL 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: 20309755
• Report Number: 9610773-2024-02342
• Device Sequence Number: 12939647
• Product Code: FGB
• UDI-Device Identifier: 04042761086387
• UDI-Public: 04042761086387
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K200369
• 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): 12/20/2024

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: WA2UR11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2022
• 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