BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULES

    MDR report key: 726337 · Received June 14, 2006

    Report

    Report Number
    1527736-2006-02717
    Event Type
    Malfunction
    Date Received
    June 14, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 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
    CA, 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 THE DC MOTOR ADAPTOR TO BE REPLACED. THE DEVICE WAS FUNCTIONALLY TESTED, MET ALL PRODUCT REQUIREMENTS AND RETURNED TO THE CUSTOMER. THE PMA/510(K)K99190.

    Description of Event or Problem · 1

    MOTOR ADAPTOR IS BROKEN ON THE GREEN CABLE SIDE. THE REP WAS NOT PRESENT AND NOT INFORMED OF ANY ERRORS. THE CUSTOMER USED ANOTHER CONTROL MODULE FOR THE CASE WITH NO PT 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 HOLSTER| PROBE