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

Model Number	URF-V
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: water/air leakage from soft/ curved part - perforation, cut, or flaw in curved part, water/air leakage from channel - hole caused by treatment tool (handling problem), roughness when rotating mechanism is activated, scratches on rotating mechanism, bending tube broken, scratch on insertion part, scratches on universal cord and video cable chipped curved rubber adhesion part, scratches on video connector, scratches on lg connector, scratches on video connector case, light guide cover glass discoloration, scratches on actuator, switch-box, scratches on actuator cover, scratches on grip, scratches on angulation lever, scratches on the insertion part and corrosion on actuator.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the uretero-reno videoscope had an air leak.The issue was found during an unknown event.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: forceps stopper is loose.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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, a definitive root cause of the observed loose forceps cap issue could not be determined, however, the issue was likely the result physical and or external factors.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Common Device Name: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18489781
• Report Number: 3002808148-2024-00368
• Device Sequence Number: 6985228
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2012
• 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