BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC VACUUM-ASSISTED BREAST BIOPSY DEVICE

    MDR report key: 1001466 · Received February 13, 2008

    Report

    Report Number
    3003862400-2008-00005
    Event Type
    Other
    Date Received
    February 13, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 13, 2008
    Manufacturer
    HOLOGIC, INC. INTERVENTIONAL BREAST SOLUTIONS
    Product Code
    KNW
    PMA / PMN Number
    K042290
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REP OF THE INTERVENTIONAL BREAST SOLUTIONS DIVISION OF HOLOGIC, INC. REPORTED THAT THE HANDPIECE WAS FOUND WITHOUT A TISSUE FILTER IN THE CHAMBER AT SET-UP PROCEDURE. THE REP REPLACED THE FILTER SO THAT THE PROCEDURE COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC VACUUM-ASSISTED BREAST BIOPSY DEVICE VACUUM ASSISTED CORE BIOPSY DEVICE KNW HOLOGIC, INC. INTERVENTIONAL BREAST SOLUTIONS ATEC 0909-20 801065

    Patients

    Seq Age Sex Outcome Treatment
    1