BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3944307 · Received May 8, 2014

    Report

    Report Number
    1717344-2014-00406
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLEAR INSULATION WAS DAMAGED. THE DEVICE FAILED HIPOT TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLEAR INSULATION BECAME DAMAGED 2.5 HOURS INTO A LAPAROSCOPIC COLECTOMY. NOTHING FELL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278153 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 32560008X

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR