BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V

    MDR report key: 1621313 · Received February 22, 2010

    Report

    Report Number
    3005075853-2010-00797
    Event Type
    Malfunction
    Date Received
    February 22, 2010
    Date of Event
    December 22, 2009
    Report Date
    December 24, 2009
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE SERVICE THE EX UPGRADE AND THE DC MOTOR ADAPTER UPGRADE WERE PERFORMED. THE UNIBOARD, THE PUMP ISOLATION MOUNTS, THE FLAT WASHERS, THE HDW WASHERS AND THE PUMP WERE REPLACED BECAUSE THEY WERE DEFECTIVE. THERE WAS NO PT INVOLVEMENT.

    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 PROBE| HOLSTER