BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC -20/240V

    MDR report key: 1100044 · Received August 5, 2008

    Report

    Report Number
    3005075853-2008-00923
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 18, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER'S COMPLAINT AND FOUND THE UNIBOARD WAS THE CAUSE FOR THE LOUD BANG AND CAUSED THE TOUCH SCREEN TO TURN OFF. TO CORRECT THE CUSTOMER'S COMPLAINT, THE ANALYSIS SITE REPLACED THE UNIBOARD, AND PER THE SVC MANUAL PERFORMED SVC TEST WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SVC PROCESS, REPLACED THE MUFFLER AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. THE UNIT HAS NOT BEEN RETURNED FOR SVC PRIOR TO THIS EVENT, THEREFORE, NO SVC 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, THE DEVICE SUDDENLY MADE A LOUD "BANG" AND THE TOUCH SCREEN TURNED OFF. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE. 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 CONTROL MODULE| PROBE