MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 6,4/7,8 FR. X 330 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL

Model Number	WA29049A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the ureteroscope, 6,4/7,8 fr.X 330 mm, 7°, straight ocular angle, 4,2 fr.Channel had a bent shaft.The issue was found during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed as the shaft was bent.The following non-reportable malfunctions were found during the device evaluation: the distal edge had dents, the image was blurry.The investigation is ongoing and 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.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 likely cause of the reported event is due to excessive force by the customer.However, the root cause of the reported event is unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 6,4/7,8 FR. X 330 MM, 7°, STRAIGHT OCULAR ANGLE, 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: 18352002
• Report Number: 9610773-2023-03681
• Device Sequence Number: 8424717
• Product Code: FGB
• UDI-Device Identifier: 04042761063043
• UDI-Public: 04042761063043
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: Health Professional
• Device Model Number: WA29049A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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