BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE

    MDR report key: 1001133 · Received February 15, 2008

    Report

    Report Number
    1717344-2008-00050
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    December 18, 2007
    Report Date
    January 16, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 DURING A THYROIDECTOMY, THE BLUE NYLON INSULATION MELTED AND STUCK TO THE PT'S TISSUE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE PRECISE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 127701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK