BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4140689 · Received October 3, 2014

    Report

    Report Number
    1717344-2014-00871
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 12, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAWS WOULD NO LONGER OPEN AFTER THE DEVICE HAD SEALED AND CUT THE PATIENT¿S TISSUE. THE DEVICE WAS REMOVED FROM THE PATIENT BY RESECTING TISSUE ADJACENT TO THE JAWS. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619782 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF5544 41920133X

    Patients

    Seq Age Sex Outcome Treatment
    1