BEUDAMED
    FDA Adverse Event Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 7027348 · Received November 13, 2017

    Report

    Report Number
    MW5073286
    Date Received
    November 13, 2017
    Date of Event
    September 26, 2016
    Report Date
    November 1, 2017
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803170 INTUITIVE SURGICAL INC. DA VINCI XI LARGE CLIP APPLIER NAY INTUITIVE SURGICAL INC. DA VINCI XI N10160209-0033

    Patients

    Seq Age Sex Outcome Treatment
    1