BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULES

    MDR report key: 726347 · Received June 14, 2006

    Report

    Report Number
    1527736-2006-02715
    Event Type
    Malfunction
    Date Received
    June 14, 2006
    Report Date
    May 24, 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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INQUIRY INFORMATION RECIEVED VISUAL AND FUNCTIONAL EXAMINATION: THE UNIT WAS FOUND TO REQUIRE THE CD MOTR 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

    THE DEVICE DID NOT WORK: IT SHOWED ERROR L3-002.

    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 HOLSTE| PROBE