BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1122052 · Received August 14, 2008

    Report

    Report Number
    3005075853-2008-01238
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Report Date
    July 31, 2008
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/14/2008. EVALUATION SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE PER THE SERVICE MANUAL PERFORMED SERVICE TESTS WITH THE UNIT PASSING ALL TESTS AND NO FUNCTIONAL FAULTS WERE FOUND. PER THE CUSTOMER REQUEST, TWO DC MOTOR ADAPTERS, ROTATIONAL CONNECTOR SOCKET, TRANSLATIONAL CONNECTOR SOCKET, 2 JAM NUTS, AND THE HOLSTER CABLE WERE REPLACED. AS PART OF THE STANDARD SERVICE PROCESS, THE MUFFLER WAS REPLACED AND DOW CORNING LUBRICANT WAS APPLIED TO THE DC MOTORS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REQUESTED TO HAVE A REPLACEMENT OF CONNECTORS ON FRONT OF THE CONTROL MODULE. NO PT OR PROCEDURE INVOLVEMENT. NOT FOR HUMAN USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1