BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V

    MDR report key: 1081748 · Received July 18, 2008

    Report

    Report Number
    3005075853-2008-00575
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 7, 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
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THAT A BROKEN DC MOTOR ADAPTER THE BLUE CABLE CONNECTOR WAS CAUSING THE UNIT NOT TO CUT AND MAKE LOUD NOISES. TO CORRECT THIS ISSUE THE ANALYSIS SITE REPLACED THE DC MOTOR ADAPTER. PER THE SERVICE MANUAL, SERVICE TEST WERE PERFORMED WITHIN NO FUNCTION FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED THE MUFFLER, APPLIED LOCTITE TO THE HAND/FOOT SWITCH CONNECTOR, AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. ALSO, PERFORMED THE DC MOTOR ADAPTER UPGRADE. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE, NO SERVICE HISTORY REVIEW CAN BE DONE. 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 AN UNKNOWN PROCEDURE THE CONTROL MODULE HAD AN EXTRANEOUS NOISE. IT WAS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V KNW ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| PROBE