BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1032397 · Received April 17, 2008

    Report

    Report Number
    1717344-2008-00159
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Report Date
    February 11, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE LIGASURE V WAS IN USE DURING A SLEEVE GASTRECTOMY. WHEN THE SURGEON FIRED THE DEVICE, THE ACTIVATION TONE WAS HEARD AND THE CUSTOMER REPORTS THAT THERE WAS SMOKE AT THE SEAL AREA, BUT THAT THE PT'S TISSUE WAS NOT SEALED. THE LIGASURE HANDPIECE WAS BEING USED WITH A LIGASURE SYS GENERATOR SET AT 3 BARS OF POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 131340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIGASURE SYSTEM GENERATOR