BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCED MONOPOLAR SEALER/DIVIDER

    MDR report key: 2926574 · Received January 18, 2013

    Report

    Report Number
    2926574
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AFTER MULTIPLE FIRES, THE INSTRUMENT WOULD NOT CUT. THEN GENERATOR, HANDPIECE, PATIENT, AND CORDS WERE ALL INSPECTED. NO IMMEDIATE HARM WAS DONE TO THE PATIENT. A NEW HANDPIECE WAS OPENED AND WAS FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27900 LIGASURE ADVANCED MONOPOLAR SEALER/DIVIDER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE * 243967X

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR