BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI

    MDR report key: 3113448 · Received April 29, 2013

    Report

    Report Number
    3113448
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 29, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC ROBOTIC ASSISTED TAH, SURGEON NOTED THAT THE ENDOWRIST INSTRUMENT, MARYLAND BIPOLAR FORCEPS 8MM HAD SPARKED WHILE IN USE AND THE TIPS WERE NOT CLOSING PROPERLY. HE STATED THAT THERE WAS NO HARM TO THE PATIENT. THE INSTRUMENT WAS REMOVED FROM THE FIELD AND REPLACED WITH ANOTHER BIPOLAR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185289 DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED NAY INTUITIVE SURGICAL, INC. * M10120529 864

    Patients

    Seq Age Sex Outcome Treatment
    1 *