MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number	URF-V3R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus, at the end of the ureteroscopy procedure, pieces of the outer layer (bending section near the distal tip) on the uretero-reno videoscope were found to be broken off in the patient's bladder.The pieces were retrieved with an alligator grasper.There was no procedural delay and no additional imaging was required as a result of the issue.The defect in the scope matched the retrieved pieces.The device was inspected before use with no anomalies.No patient harm was reported.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Common Device Name: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 18446596
• Report Number: 2429304-2024-00006
• Device Sequence Number: 7155177
• Product Code: FGB
• UDI-Device Identifier: 04953170435133
• UDI-Public: 04953170435133
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/04/2024
• Report Date (Section F): 12/11/2023

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: URF-V3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2023
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown