BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 7194012 · Received January 12, 2018

    Report

    Report Number
    MW5074583
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 3, 2018
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLACK ENERGY CABLE IDENTIFIED "STRETCHED" OUT OF ITS NORMAL POSITION. TAKEN OUT OF SERVICE AND RETURNED TO VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32281 INTUITIVE SURGICAL INC. DA VINCI SI MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL INC. DA VINCI SI N10170821

    Patients

    Seq Age Sex Outcome Treatment
    1