BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME* CONTROL MODULE WITH SMARTVAC* - 120V

    MDR report key: 1032244 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02288
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 3, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE UNIBOARD WAS THE CAUSE FOR THIS ISSUE. TO CORRECT THE ISSUE, THE ANALYSIS SITE REPLACED THE UNIBOARD. PER THE SERVICE MANUAL, SERVICE TEST WERE PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED THE MUFFLER AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. AFTER SERVICING, THE UNIT PASSED QA FUNCTIONAL TESTING. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED ALL PREVIOUS QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A STEREOTACTIC BREAST BIOPSY THE LATERAL TUBING BROKE OFF OF THE PROBE AFTER BEING FIRED INTO THE BREAST. A SECOND PROBE WAS USED AND IT WAS NOTICED THE SAMPLES WERE POOR OR MISSING. THE CASE WAS COMPLETED WITH THE SECOND PROBE WITH NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME* CONTROL MODULE WITH SMARTVAC* - 120V KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| HOLSTER