BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1190484 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03416
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/03/2008. INFO NOT PROVIDED. EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER'S COMPLAINT AND FOUND THE DC ADAPTER WAS THE CAUSE. TO CORRECT THE CUSTOMER'S COMPLAINT THE ANALYSIS SITE REPLACED THE DC ADAPTER. PER THE SERVICE MANUAL PERFORMED SERVICE TESTS, WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED THE MUFFLER AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE, NO SERVICE HISTORY REVIEW CAN BE DONE. 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 DURING A BREAST BIOPSY PROCEDURE VERY SMALL FRAGMENTED SAMPLES WERE BEING RECEIVED. THERE WAS NO PT CONSEQUENCE REPORTED. CASE WAS COMPLETED USING THE UNIT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| HOLSTER