BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXS ANGLED LIGASURE

    MDR report key: 1904240 · Received November 17, 2010

    Report

    Report Number
    MW5018244
    Event Type
    Other
    Date Received
    November 17, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 8, 2010
    Manufacturer
    VALLEY LAB
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON COULD NOT GET FOOT ACTIVATED HANDPIECE TO ADEQUATELY CONTROL BLEEDING AND WAS BEING DIRECTED BY THE MACHINE TO REGRASP TISSUE SAMPLE. STAFF THEN REQUESTED YET ANOTHER HANDPIECE THAT WAS HAND ACTIVATED WHICH DID WORK PROPERLY. SURGEON WAS ABLE TO PERFORM OTHER PORTIONS OF THE SURGERY WHILE THE ADD'L EQUIPMENT WAS OBTAINED SO NO DELAY TO THE PT. CASE WAS ABLE TO BE COMPLETED AS PLANNED. THIS SURGEON HAS BEEN USING THIS EQUIPMENT AND TECHNOLOGY FOR YEARS PRIOR TO THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXS ANGLED LIGASURE GEI VALLEY LAB 150404

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR