BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST HOT SHEARS

    MDR report key: 2842683 · Received October 10, 2012

    Report

    Report Number
    2842683
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    October 10, 2012
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SURGEON NOTED THE INSTRUMENT WAS ARCING UNINTENTIONALLY, AND BURNED THE UTERUS. THE TIP WAS CHANGED OUT AND IT CONTINUED TO ARC. A NEW INSTRUMENT WAS OPENED AND FUNCTIONED WITH NO PROBLEMS. IT IS UNKNOWN IF THE NEW INSTRUMENT WAS OF THE SAME OR A DIFFERENT LOT.======================MANUFACTURER RESPONSE FOR MONOPOLAR CURVED SCISSORS, DA VINCI MONOPOLAR CURVED SCISSORS (PER SITE REPORTER).======================THEY WANT THE DEVICE BACK WITHIN A VERY SHORT PERIOD OF TIME OR THEY RESERVE THE RIGHT TO CANCEL THE RMA WITHOUT NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST HOT SHEARS MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL * M10120711 637

    Patients

    Seq Age Sex Outcome Treatment
    1 *