BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1182827 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03737
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/16/2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROL MODULE WAS GETTING GREEN CABLE ERRORS WITH THE HOLSTER DURING A BREAST BIOPSY. A DIFFERENT HOLSTER WAS USED AND THE SAME GREEN CABLE ERRORS OCCURRED. THE CUSTOMER TRIED A SECOND CONTROL MODULE WITH THE FIRST HOLSTER AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V NONE KNW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA 1201946

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE