BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1032410 · Received April 14, 2008

    Report

    Report Number
    1717344-2008-00147
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 14, 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 THE JAWS OF THE LIGASURE V JAMMED SHUT ON PT TISSUE DURING A NEPHRECTOMY. THE DEVICE ALSO STOPPED CUTTING AFTER THE THIRD APPLICATION. ANOTHER LIGASURE V HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 134131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK