BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 837595 · Received February 23, 2007

    Report

    Report Number
    1717344-2007-00055
    Event Type
    Malfunction
    Date Received
    February 23, 2007
    Date of Event
    January 25, 2007
    Report Date
    January 26, 2007
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE SURGEON ACTIVATED THE DEVICE ON THE INFERIOR MESENTERIC ARTERY. AFTER THE THIRD SEAL, THE JAWS WOULD NOT OPEN SINCE THE RATCHET DID NOT RETURN. THE SURGEON CLIPPED THE TISSUE AND REMOVED THE DEVICE FROM THE CAVITY. THERE WAS NO REPORT OF BLEEDING AND THE DEVICE WAS USED PROPERLY AFTER CLEANING THE JAWS. THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER ESU HANDPIECE GEI VALLEYLAB * 103989

    Patients

    Seq Age Sex Outcome Treatment
    1 YR