BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI

    MDR report key: 3202280 · Received June 25, 2013

    Report

    Report Number
    MW5030708
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 25, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DAVINCI SINGLE SITE MARYLAND BIPOLAR INSTRUMENT BEGAN SMOKING IN AN UNUSUAL MANNER, SO IT WAS REPLACED. THE "2 NO" MARYLAND ALSO BEGAN SMOKING UNUSUALLY AS THE FIRST, BUT IT ALSO MELTED THE PLASTIC AT THE JOINT/HINGE. THE MELTED PORTION PREVENTED THE INSTRUMENT FROM BEING REMOVED THROUGH THE TROCAR/PORT. THE ENTIRE PORT HAD TO BE REMOVED. BOTH EPISODES OCCURRED WHILE THE INSTRUMENT WAS IN USE IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288025 DAVINCI SINGLE SITE BIPOLAR MARYLAND FORCEP NAY INTUITIVE SURGICAL 428080 510130329

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention