BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1191258 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03641
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: UNIBOARD. EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT OF A "BURNING SMELL WHEN DOING A PROCEDURE" AND FOUND THIS WAS CAUSED BY THE VACUUM PUMP AND THE CAPACITOR. TO CORRECT THIS ISSUE, THE SITE REPLACED THE VACUUM PUMP, FOUR PUMP MOUNT SCREWS, TWO FENDER WASHERS, TWO FLAT WASHERS, AND THE CAPACITOR. THE VSO WAS REPLACED DUE TO THE UNIT HAD INADEQUATE VACUUM SWING, THE UNIBOARD WAS REPLACED DUE TO THE UNIT DISPLAYED AN L4-003 ERROR CODE AND FAILED INTERNAL ENCODER TEST, AND THE BEZEL WAS REPLACED DUE TO IT WAS CRACKED. TWO ADHESIVE DOTS WERE REPLACED, DUE TO THEY WERE MISSING FROM THE BACK OF THE LCD. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED THE MUFFLER, AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA IN 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 THE CONTROL MODULE WAS GIVING A BURNING SMELL WHEN DOING A BREAST BIOPSY PROCEDURE. THERE HAVE BEEN NO PT CONSEQUENCES REPORTED.

    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 HOLSTER| PROBE