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

Model Number	URF-V3
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the reno videoscope exhibited foreign object near the forceps outlet.The issue is unknown as to when it occurred.There were no reports of delay, patient harm, injury, or death.Additional details relating to the patient and the event have been requested, but no response has been received at this time.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h3, h6.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 foreign material could not be identified; therefore, a root cause could not be determined.Additionally, there was physical damage on the device.The events can be detected and prevented in accordance with the following sections of the instructions for use: "the instruction manual operation manual ¿urf-v3, chapter 3 preparation and inspection¿ describes the methods for detection.The instruction manual reprocessing manual ¿urf-v3, chapter 5 reprocessing the endoscope¿ describes the methods for prevention." olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20476620
• Report Number: 9610595-2024-21308
• Device Sequence Number: 7629857
• Product Code: FGB
• UDI-Device Identifier: 04953170435119
• UDI-Public: 04953170435119
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: URF-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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