BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 3221744 · Received July 5, 2013

    Report

    Report Number
    MW5030825
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 8, 2013
    Manufacturer
    COVIDIEN SURGICAL DEVICES
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SLEEVE GASTRECTOMY PROCEDURE THE LIGASURE WAS PLUGGED INTO THE APPROPRIATE MACHINE. THE SURGEON ALERTED STAFF THAT THE LIGASURE WAS "NOT WORKING". A REPLACEMENT LIGASURE WAS OPENED AND DID NOT WORK EITHER. THE PROCEDURE WAS COMPLETED USING ANOTHER VENDOR'S PRODUCT. THERE WAS NO HARM TO THE PT. FURTHER DETAILS CAN BE OBTAINED FROM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307334 COVIDIEN LIGASURE ADVANCE 5MM - 44CM GEI COVIDIEN SURGICAL DEVICES REF LF5544 251409X

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR