BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1834588 · Received December 11, 2007

    Report

    Report Number
    1527736-2007-08406
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    January 1, 2007
    Report Date
    October 29, 2007
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND PERFORMED SERVICE TESTS AND FOUND THE WIRES PULLED OUT OF CONNECTOR ON THE IF BOARD, CONFIRMING THE CUSTOMERS COMPLAINT OF NOT RECOGNIZING THE HOLSTER BEING CONNECTED, AND TO CORRECT THIS COMPLAINT THE ANALYSIS SITE REPLACED THE HOLSTER: IF BOARD TO BEZEL. THE VSO WAS REPLACED DUE TO THE SITE FOUND THAT IT FAILED IN TESTING, THE MAIN HOUSING MOUNTS WERE BROKEN ON THE INSIDE AND THE SITE REPLACED THE MAIN HOUSING, TUBING BULKHEAD GASKET, AND THE BEZEL ROPE GASKET TO CORRECT THE MAIN HOUSING ISSUE,AND THE PUMP MOUNT SCREWS (4), THE PUMP MOUNTS (4), FENDER WASHERS (4), AND FLAT WASHER (4) WERE REPLACED DUE TO THE PUMP MOUNTS WERE DAMAGED. AFTER SERVICING THE UNIT PASSED ALL QA FUNCTIONAL TESTING. 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

    IT WAS REPORTED THAT THE X-RAY TABLE WAS ACCIDENTALLY LOWERED ONTO THE CONTROL MODULE. THE CUSTOMER STATED THAT THERE IS NO VISIBLE DAMAGE TO CONTROL MODULE BUT IT WILL NOT RECOGNIZE HOLSTER BEING CONNECTED. NO PT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PROBE| HOLSTER