BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELERO-12 VACUUM ASSISTED BIOPSY DEVICE

    MDR report key: 1422682 · Received April 21, 2009

    Report

    Report Number
    3003862400-2009-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2009
    Date of Event
    March 23, 2009
    Report Date
    April 21, 2009
    Manufacturer
    HOLOGIC, INC.
    Product Code
    KNW
    PMA / PMN Number
    K034021
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN OF DEVICE TO HOLOGIC, INC. BY CUSTOMER FOR EVALUATION OF FAILURE. TO OUR KNOWLEDGE, THE PATIENT REQUIRED NO MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    DURING TISSUE ACQUISITION PROCEDURE, TECHNICIAN WENT TO FIRE OUTER CANNULA BY DEPRESSING DEVICE'S FIRING BUTTON (BLUE BUTTON) AND THE OUTER CANNULA DID NOT FIRE AS EXPECTED. THE TECHNICIAN WAS INJURED WHILE TRYING TO REMOVE AN ACQUIRED TISSUE SAMPLE FROM THE APERTURE OF THE NEEDLE WHEN THE OUTER CANNULA FIRED (DELAYED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELERO-12 VACUUM ASSISTED BIOPSY DEVICE VACUUM ASSISTED BIOPSY DEVICE KNW HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1