MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number	CYF-V2
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the cysto-nephro videoscope experienced the scope was blown due to pressure cap not being attached.The issue occurred during preparation for use.There were no reports of patient harm.
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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was not confirmed.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined.The instructions for use warns the prevention method associated with the event in: instructions visera cysto-nephro videoscope, olympus cyf type v2, olympus cyf type va2, olympus cyf type v2r, chapter 6 compatible reprocessing methods and chemical agents and chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: CYSTO-NEPHRO 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: 19623776
• Report Number: 3002808148-2024-05839
• Device Sequence Number: 15061467
• Product Code: FAJ
• UDI-Device Identifier: 04953170287091
• UDI-Public: 04953170287091
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221683
• 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): 08/06/2024

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: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2010
• 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