BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2890524 · Received December 4, 2012

    Report

    Report Number
    2890524
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    July 10, 2012
    Report Date
    November 7, 2012
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    AN ERROR CAME ACROSS THE DAVINCI SCREEN SAYING REMOVE INSTRUMENT FROM PATIENT. DEVICE TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INSTRUMENT, ROBOTIC SURGICAL, HARMONIC CURVED SHEARS NAY INTUITIVE SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR