BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULES

    MDR report key: 726459 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02690
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Date of Event
    May 31, 2006
    Report Date
    June 1, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    k99190
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H4: INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. 510(K) NUMBER IS K99190.

    Description of Event or Problem · 1

    THE CUTTER STOPPED CUTTING AFTER SEVERAL SAMPLES DURING A BREAST BIOPSY. THE SAMPLES ATTAINED CONTAINED THE NEEDED CALIFICATIONS, THE PROBE WAS REMOVED SUCCESSFULLY AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE. IT WAS NOTICED THE DC MOTOR ADAPTER FOR THE CUTTER WAS BROKEN OFF IN THE CABLE FOR THE ST HOLSTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULES KNW KNW ETHICON ENDO SURGERY, INC.(CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 1.PROBE, 2.HOLSTER.