BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 7027329 · Received November 13, 2017

    Report

    Report Number
    MW5073278
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    August 12, 2016
    Report Date
    November 1, 2017
    Manufacturer
    INTUITIVE SURGICAL NC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT GRIP CABLE BROKEN / FRAYED ON DISTAL END. FAILURE ANALYSIS INVESTIGATIONS FOUND BROKEN - DISTAL ON THE FOLLOWING LOCATION INSTRUMENT GRIP CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803142 INTUITIVE SURGICAL INC. DA VINCI XI PROGRASP FORCEPS NAY INTUITIVE SURGICAL NC. DA VINCI XI S10160201-0033

    Patients

    Seq Age Sex Outcome Treatment
    1