MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 7,5 FR. X 430 MM, 7°, 2 CHANNELS, STRAIGHT OCULAR ANGLE; WA02944A

Model Number	WA02944A
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure, the ureteroscope had a bent with broken light fibers.This issue prolonged the procedure for more than 30 minutes while the patient was under sedation.The procedure was then completed with the same device.There were no reports of patient harm.
Event or Problem Description
No additional information was received from the customer.No additional information was received from the customer.As no additional information obtained, it was determined that there was no harm to the patient as initially reported.No additional information was received from the customer.As no additional information obtained, it was determined that there was no harm to the patient as initially reported.This event was initially conservatively reported as a serious injury; however, there is no evidence the patient suffered any serious injury or adverse effects from the prolonged procedure.Olympus made multiple attempts to receive more information from the customer without success.Thus correcting b1 and b2.B1 should not be marked as an adverse event but product problem only, and b2 should not be marked at all.Updated f10 health effect - impact code to f26.

• Brand Name: URETEROSCOPE, 7,5 FR. X 430 MM, 7°, 2 CHANNELS, STRAIGHT OCULAR ANGLE
• Common Device Name: WA02944A
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 21037122
• Report Number: 2429304-2024-01057
• Device Sequence Number: 8419759
• Product Code: FGB
• UDI-Device Identifier: 04042761029544
• UDI-Public: 04042761029544
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025
• Report Date (Section F): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA02944A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/07/2025
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 08/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/27/2025