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

Model Number	URF-P7R
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the uretero-reno fiberscope had damage to the main channel.The issue occurred during setup.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d9, h2, h3, h4, h6, h11.The device was returned to olympus for inspection and the reported failure was not confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction.The most probable cause is normal use of the device, and therefore cause not established: the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported the uretero-reno fiberscope had damage to the main channel.The issue occurred during setup.There were no reports of patient harm.

• Brand Name: URETERO-RENO FIBERSCOPE
• Common Device Name: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20746414
• Report Number: 9610595-2024-40065
• Device Sequence Number: 8362521
• Product Code: FGB
• UDI-Device Identifier: 04953170435102
• UDI-Public: 04953170435102
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K181451
• 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): 01/06/2025

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: URF-P7R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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