BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER

    MDR report key: 3831945 · Received May 20, 2014

    Report

    Report Number
    3831945
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 20, 2014
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DOCTOR NOTICED THE VESSEL SEALER WAS NOT REGISTERED ON THE ROBOT AND SAW THAT THE LIGHT ABOVE THE CORD WHICH SHOULD BE BLUE WAS RED. HE CALLED INTUITIVE AND THEY ADVISED HIM TO GET A NEW CORD AND RESTART THE ROBOT. WHEN HE DID THIS, IT REGISTERED THE NEW VESSEL SEALER. THE COMPANY WANTED HIM TO SEND THE CORD AND INSTRUMENT VESSEL SEALER IN THAT DID NOT REGISTER TO CHECK FOR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299150 ENDOWRIST ONE VESSEL SEALER SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL INC. 410322 S10131204

    Patients

    Seq Age Sex Outcome Treatment
    1 *