BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE

    MDR report key: 3113354 · Received May 8, 2013

    Report

    Report Number
    3113354
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 8, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DAVINCI VESSEL SEALER MALFUNCTIONED DURING SURGERY. BLADE WOULD NOT RETRACT BACK. NO HARM WAS DONE TO PATIENT. DEVICE WAS INTACT UPON INSPECTION.MANUFACTURER REQUESTS DEVICE(S)FOR EVALUATION. THIS IS THE 4TH DEFECTIVE DEVICE. LOCAL REP IS SUPPOSED TO PICK UP PRODUCTS FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?GYN PROCEDURE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202292 ENDOWRIST ONE INSTRUMENT, COMPUTER CONTROLLED, VESSEL SEALER NAY INTUITIVE SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR