BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2980502 · Received January 31, 2013

    Report

    Report Number
    1717344-2013-00011
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 8, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BLADE STARTED STICKING DURING A SLEEVE GASTRECTOMY. A PIECE OF THE DEVICE HAD BROKEN OFF AND FALLEN INTO THE PT'S CAVITY. IT WAS RETRIEVED WITHOUT HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41943 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 245171X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK