BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC -20/240V

    MDR report key: 1112779 · Received August 12, 2008

    Report

    Report Number
    3005075853-2008-01109
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    June 2, 2008
    Report Date
    July 1, 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 COMPLAINT, AND FOUND THIS WAS DUE TO THE CONNECTOR J1 ON THE UNIBOARD. THE SITE ALSO FOUND THE LCD TOUCH SCREEN WOULD NOT FUNCTION, DUE TO THE UNIBOARD. TO CORRECT THE CUSTOMER COMPLAINT, THE ANALYSIS SITE REPLACED THE UNIBOARD. DUE TO FLUID INGRESSION, THE FOLLOWING COMPONENTS WERE HEAVILY CORRODED AND RUSTED AND WERE REPLACED: BASEPLATE, VACUUM PUMP, FOUR PUMP MOUNT SCREWS, FOUR FENDER WASHERS, FOUR FLAT WASHERS, FOUR PUMP ISOLATION MOUNTS, THE BEZEL, THE CAPACITOR, AND THE TUBING ASSEMBLY. PER THE SERVICE MANUAL SERVICE TEST WERE PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED THE MUFFLER AND APPLIED DOW CORNING LUBRICANT 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

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AN ERROR CODE L4-027 WAS RECEIVED. IT WAS UNK HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. 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