BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 1003730 · Received February 20, 2008

    Report

    Report Number
    1219930-2008-00154
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: FEBRUARY 20, 2002. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. THE SITE REPLIED THAT IT WAS DISCARDED AND THEREFORE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A LAPAROSCOPIC SIGMOID PROCEDURE, THE LIGASURE LAPAROSCOPIC ATLAS WAS ACTIVATED TO SEAL PATIENT TISSUE. THE FORCETRIAD GENERATOR IN USE SOUNDED AN END TONE, INDICATING THAT THE SEALING CYCLE HAS BEEN COMPLETED SATISFACTORILY. THE SURGEON THEN ACTIVATED THE INTEGRATED CUTTER. WHEN THE JAWS OF THE ATLAS HANDPIECE WERE OPENED, IT WAS FOUND THAT THE PATIENT'S TISSUE WAS NOT SEALED. THE FORCETRIAD GENERATOR AND THE LIGASURE ATLAS HANDPIECE WERE BOTH REPLACED WITH NEW EQUIPMENT AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK