BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 1961371 · Received January 10, 2011

    Report

    Report Number
    1717344-2011-00014
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 17, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE IS NOT AVAILABLE FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULATION BOOT ON THE DEVICE WAS TORN DURING THE PROCEDURE. A PIECE OF THE INSULATION FELL INTO THE PT CAVITY AND WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other