BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

    MDR report key: 1822592 · Received November 27, 2007

    Report

    Report Number
    1527736-2007-07961
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    November 2, 2007
    Report Date
    November 2, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SETTING UP FOR A CASE, AN UNK GREEN CABLE ERROR OCCURRED WITH A LOANER HOLSTER. THE REP SEES THERE IS A CRACK IN AND AROUND THE DC MOTOR ADAPTER. THE CASE WILL BE PERFORMED TODAY WITH THE REPS CONTROL MODULE. NO PT CONSEQUENCE HAS OCCURRED.

    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 HOLSTER| PROBE