BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE TM XTD DISP ELEC/CORD

    MDR report key: 1040686 · Received May 8, 2008

    Report

    Report Number
    1717344-2008-00190
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 10, 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. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 XTD HANDPIECE DID NOT SEAL TISSUE PROPERLY DURING A HYSTERECTOMY. THE LIGASURE VESSEL SEALING SYSTEM WAS SET TO MAXIMUM POWER. THE SURGEON USED ANOTHER LIGASURE XTD HANDPIECE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE TM XTD DISP ELEC/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 135225

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK