BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 1060947 · Received June 13, 2008

    Report

    Report Number
    1717344-2008-00266
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 15, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE WAS NOT PHYSICALLY RECEIVED BUT TWO PICTURES OF THE DISTAL END WERE RECEIVED AND WILL BE USED TO EVALUATE THE INCIDENT. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE DISTAL END OF THE LIGASURE DEVICE WAS DAMAGED DURING INSERTION THROUGH A 10MM TROCAR.

    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) N8A243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK