BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC EVIVA VACUUM ASSISTED CORE BIOPSY DEVICE

    MDR report key: 2582778 · Received May 18, 2012

    Report

    Report Number
    3003862400-2012-00007
    Event Type
    Other
    Date Received
    May 18, 2012
    Date of Event
    April 19, 2012
    Report Date
    May 18, 2012
    Manufacturer
    HOLOGIC, INC.
    Product Code
    NEU
    PMA / PMN Number
    K042290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED THAT THE EVIVA VACUUM ASSISTED CORE BIOPSY DEVICE (WHEN THE BIOPSY SITE MARKING SYSTEM DEPLOYMENT GUIDE WAS PHYSICALLY INSERTED INTO THE INTRODUCER AND ATTACHED VIA SNAPPING) CAUSED BODILY FLUID TO EJECT FROM THE BACK OF THE INTRODUCER AND LAND IN THE DEVICE OPERATOR'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC EVIVA VACUUM ASSISTED CORE BIOPSY DEVICE 21 CFR 876.1075 NEU HOLOGIC, INC. EVIVA 0913-12T 201073

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SMARK EVIVA 13 SS1