MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE 6.7/8.4 FR. X 330 MM, 5°, STRAIGHT OCULAR, 4.2 FR. CHANNEL

Model Number	WA2UR12A
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
The customer reported to olympus, the sheathing tube of the ureteroscope had broken during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation, and corrections to d9 and h3.The device evaluation and the information in d9 and h3 were inadvertently omitted from the initial medwatch report.Please see updates to d9, h3, h6 and h10.The device was returned to olympus for inspection, and the customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the sheathing tube broke due to excessive force such as: bending, jamming, kinking, and/or excessive frequent use.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE 6.7/8.4 FR. X 330 MM, 5°, STRAIGHT OCULAR, 4.2 FR. CHANNEL
• Common Device Name: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16985404
• Report Number: 9610773-2023-01399
• Device Sequence Number: 15186420
• Product Code: FGB
• UDI-Device Identifier: 04042761086394
• UDI-Public: 04042761086394
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: WA2UR12A
• Device Catalogue Number: WA2UR12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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