BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME* CONTROL MODULE

    MDR report key: 1541720 · Received November 20, 2009

    Report

    Report Number
    3005075853-2009-07159
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 28, 2009
    Report Date
    October 29, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFORMATION NOT PROVIDED BASED ON ANALYSIS RESULTS, THE COMPLAINT IS NOW DETERMINED TO BE AN MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT. THE DC MOTOR ADAPTOR WAS SLIPPING CAUSING THE CUTTER TO STOP. THE LCD CONNECTOR WAS LOOSE CAUSING THE INTERMITTENT SCREEN SIGNAL. THE VACUUM PUMP WAS CAUSING THE BURNING SMELL. TO CORRECT THE ISSUES, THE ANALYSIS SITE REPLACED THE DC MOTOR ADAPTOR, LCD CONNECTOR AND THE VACUUM PUMP. AFTER SERVICING, THE UNIT PASSED ALL QA TESTING PROCEDURES. COMPLAINT INFORMATION 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 WHEN USING THE CONTROL MODULE UNDER ULTRASOUND INFLUENCE THE CUTTER STOPPED DURING THE SAMPLE MODE AND A BURNING SMELL WAS NOTICED. ALSO, THE LCD SCREEN WAS CAUSING INTERMITTENT SIGNALS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME* CONTROL MODULE MAMMOTOME* CONTROL MODULE KNW ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER AND PROBE