BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 1022314 · Received March 31, 2008

    Report

    Report Number
    1717344-2008-00118
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 1, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL 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 ATLAS WAS USED DURING A BILIARY-PANCREATIC DIVERSION. THE SURGEON REPORTED HEARING AN END TONE INDICATING THE SEAL CYCLE WAS COMPLETED SATISFACTORILY. BUT WHEN THE SURGEON OPENED THE INSTRUMENT, IT WAS FOUND THAT THE PT'S TISSUE WAS NOT SEALED, BUT THE BLADE HAD CUT THE PT'S TISSUE AND THE UNSEALED SITE WAS BLEEDING. THE SURGEON REPEATED THE SEAL CYCLE, AND AGAIN THE INSTRUMENT DIDN'T WORK BUT THE SYSTEM SOUNDED THE END TONE. THE BLOOD LOSS FROM THE CUT TISSUE WAS NOT SEVERE ENOUGH TO REQUIRE A TRANSFUSION, BUT THE EXACT AMOUNT LOST IS UNK. THE LIGASURE GENERATOR IN USE WAS SET AT 2 BARS OF POWER, OUT OF MAXIMUM OF 3 BARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N7J340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK