BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1193087 · Received October 6, 2008

    Report

    Report Number
    1717344-2008-00459
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 16, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN RECEIVED, AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATES THAT DURING A PROCEDURE, THE DEVICE STUCK TO TISSUE. ANOTHER INSTRUMENT WAS USED TO REMOVE THE DEVICE FROM THE TISSUE. THE SURGEON STATED THAT AT THE TIME OF THE INCIDENT, HE HAD A LARGE, TOUGH TISSUE BUNDLE INSIDE THE JAWS. THERE WAS NO BLEEDING OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 143127

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK