BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA VIDEO SYSTEM CENTER

    MDR report key: 19327669 · Received May 15, 2024

    Report

    Report Number
    3002808148-2024-04489
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    June 4, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170141546
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. SINCE THE DEVICE IS MORE THAN 15 YEARS OLD, THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY DUE TO THE FAILURE OF THE DIGITAL VISUAL BOARD THAT THE IMAGE IS NOT DISPLAYED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEO SYSTEM CENTER EXHIBITED INTERNAL FAILURE OF DV (DIGITAL VIDEO) BOARD CAUSING TERMINAL RATTLING AND NO DIGITAL OUTPUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617932 VISERA VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7V 04953170141546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown