BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 3915255 · Received June 19, 2014

    Report

    Report Number
    3915255
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON PREPARING FOR A ROBOTIC ASSISTED CASE, THE TECHNICIAN WAS CHECKING THE INSTRUMENTATION IN THE ROBOTIC INSTRUMENT ARM AND THE FENESTRATED BIPOLAR FORCEPS WAS NOT BEING RECOGNIZED BY THE INSTRUMENT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360229 ENDOWRIST SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE SURGICAL, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NO OTHER THERAPIES