BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 16702382 · Received April 7, 2023

    Report

    Report Number
    3002808148-2023-03495
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Report Date
    May 11, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170310461
    PMA / PMN Number
    K221683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S 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, THE ROOT CAUSE OF THE BIOPSY PORT CONNECTOR DETACHMENT, GLUE PEELING AND KEY MISSING COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. DURING THE EVALUATION, IT WAS DETERMINED THAT THE CONTROL BODY BIOPSY PORT WAS DETACHED, AND THE KEY WAS MISSING. ADDITIONALLY, THE EVALUATION REVEALED THE ADHESIVE ON BENDING SECTION COVER (A-RUBBER) WAS PEELING AND THE LIGHT GUIDE TUBE HAD SCRATCH MARKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS DURING REPROCESSING THE BIOPSY PORT CONNECTOR CAME OFF OF THE CYSTO-NEPHRO VIDEOSCOPE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754596 CYSTO-NEPHRO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE FAJ SHIRAKAWA OLYMPUS CO., LTD. CYF-VH 04953170310461

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown