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

Model Number	WA2UR11A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that the customer angled ocular semi-rigid ureteroscope was returned to the olympus service center for a reported ¿stopcock is broken¿.The customer reported problem was found at preparation for use.However, the service inspection identified the entire stop cock valve was broken off and missing.No death or injury and no impact to person or other was reported to olympus.This report is being submitted to capture the broken off component found during service inspection.
Additional Manufacturer Narrative
The repair inspection confirmed the customer¿s reported issue, the stop cock is broken off completely (not returned).The inspection also noted the distal end tip is dented and scratched with distal end light fibers.The rigid outer tube is bent and there is debris under the eyepiece window.The investigation is still in progress.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).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 root cause could not be determined.It is likely the reported event occurred due to the use of excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 4.2 FR. CHANNEL
• Common Device Name: SEMI-RIGID URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16139229
• Report Number: 9610773-2023-00183
• Device Sequence Number: 15132858
• Product Code: FGB
• UDI-Device Identifier: 04042761086387
• UDI-Public: 04042761086387
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: WA2UR11A
• Device Catalogue Number: WA2UR11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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