BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 7316465 · Received March 5, 2018

    Report

    Report Number
    MW5075662
    Event Type
    Malfunction
    Date Received
    March 5, 2018
    Date of Event
    February 2, 2018
    Report Date
    February 20, 2018
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    JAWS WOULD NOT ENTIRELY CLOSE WHICH WILL NOT ALLOW THE LIGA CLIPS TO PROPERLY ENGAGE AND REMAIN CLOSED. (SECOND OF TWO INSTRUMENTS TO FAIL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155507 INTUITIVE SURGICAL INC. DA VINCI XI MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL INC. DA VINCI XI N10170516-0033

    Patients

    Seq Age Sex Outcome Treatment
    1