BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 1842649 · Received September 20, 2010

    Report

    Report Number
    MW5017507
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 30, 2010
    Manufacturer
    VALLEYLAB/TYCO HEALTHCARE GROUP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MD WAS USING THE LIGASURE VESSEL SEALING INSTRUMENT WHILE DOING A LAPAROSCOPIC CASE. MD HAD INSERTED THE INSTRUMENT INTO THE TROCAR AND WAS POSITIONING THE LIGASURE "TEETH" AROUND A PIECE OF TISSUE AND SHE WANTED TO SEAL. THE INSTRUMENT FIRED AND CAUTERIZED THE TISSUE BEFORE THE MD ENGAGED THE EQUIPMENT. TISSUE WAS SEALED OR "BURNED" WITHOUT INTENTION. MD REMOVED THE DISPOSABLE INSTRUMENT FROM THE ABDOMEN AND ASKED FOR ANOTHER PIECE OF EQUIPMENT AND DISPOSABLE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE VESSEL SEALING INSTRUMENT GEI VALLEYLAB/TYCO HEALTHCARE GROUP S9MBO44

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR