BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULES

    MDR report key: 726486 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02687
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Report Date
    May 12, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K99190
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INQUIRY INFORMATION RECEIVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THEVACUUM PUMP, INTERFACE BOARD AND BLACK CABLE TO BE REPLACED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER. INTERFACE BOARD AND BLACK CABLE REPLACED, VACUUM PUMP REPLACED. (510(K)#K99190)

    Description of Event or Problem · 1

    DURING A PROCEDURE LAST WEEK THE CUSTOMER RECIEVED MULTIPLE ERROR CODES AND THE CONTROL MODULE WAS SMOKING. THE ACCOUNT REPLACED THE VACUUM TUBING AND REBOOTED THE SYSTEM AND WERE ABLE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOTOME CONTROL MODULES KNW KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PROBE, HOLSTER