BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIVA

    MDR report key: 3250771 · Received June 5, 2013

    Report

    Report Number
    3250771
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TESTED EVIVA 20MM 9G BIOPSY PROBE PRIOR TO USE. BUTTON USED TO ADVANCE PROBE FORWARD INTO THE BREAST FAILED TO WORK. NEW BIOPSY PROBE USED TO FINISH THE PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?STEREOTACTIC GUIDED RIGHT BREAST BIOPSY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249468 EVIVA INSTRUMENT, BIOPSY KNW HOLOGIC, INC. * 302014

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR