BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER

    MDR report key: 3151763 · Received June 3, 2013

    Report

    Report Number
    MW5030449
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE VESSEL SEALER COAGULATED BUT DID NOT FULLY CUT THE TISSUE AS EXPECTED. ANOTHER VESSEL SEALER WAS OPENED AND USED WITH THE SAME RESULT. THE SURGEON INVOLVED USES THESE DEVICES ON A REGULAR BASIS WITHOUT INCIDENT. REASON FOR USE: ROBOTIC PROSTATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243823 ENDOWRIST ONE VESSEL SEALER VESSEL SEALER NAY INTUITIVE SURGICAL 410322 S11130402

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR