BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 1032125 · Received April 16, 2008

    Report

    Report Number
    1717344-2008-00157
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 19, 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 RETURNED. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED OF THE CUSTOMER. IF THE INCIDENT SAMPLE IS RETURNED OR ADDITIONAL INFO PERTINENT TO THE INCIDENT IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT AFTER 5 MINUTES OF USE THE INSTRUMENT JAMMED. ANOTHER LIGASURE V HANDPIECE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 133737

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK