BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATEC 1212-20 HANDPIECE

    MDR report key: 813561 · Received February 1, 2007

    Report

    Report Number
    3003862400-2007-00005
    Event Type
    Other
    Date Received
    February 1, 2007
    Date of Event
    January 12, 2007
    Report Date
    January 31, 2007
    Manufacturer
    SUROS SURGICAL SYSTEMS, INC.
    Product Code
    GDF
    PMA / PMN Number
    k042290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS USING THE ATEC 1212-20 HANDPIECE (LOT 611015) DURING AN ULTRASOUND PROCEDURE. WHEN TRYING TO DISENGAGE THE NEEDLE FROM THE HANDPIECE, THE DOCTOR PIERCED HIMSELF WITH THE TROCHAR TIP OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATEC 1212-20 HANDPIECE VACUUM ASSISTED CORE BIOPSY DEVICE GDF SUROS SURGICAL SYSTEMS, INC. ATEC 1212-20 611015

    Patients

    Seq Age Sex Outcome Treatment
    1 *