BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD

    MDR report key: 2103117 · Received May 13, 2011

    Report

    Report Number
    2103117
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    January 27, 2010
    Report Date
    March 7, 2010
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE BEGINNING OF THE CASE, USER APPLIED THE BOVIE PAD TO THE PT'S BUTTOCK, PUT THE SETTINGS TO 35CT CUT / 35CG COAGULATION AND PLUGGED IN THE BOVIE PENCIL HANDPIECE TO THE FORCED TRIAD MACHINE. AFTER THE SURGEON MADE INCISION WITH THE KNIFE, HE TOOK THE BOVIE PENCIL TO USE. UPON PUSHING THE COAG BUTTON, THE MACHINE BEEPED AND WOULDN'T WORK. ALL THREE SCREENS LIT UP FOR SEVERAL SECONDS AND THEN STARTED TO WORK. THIS HAPPENED A COUPLE TIMES THROUGHOUT THE PROCEDURE. NOT MUCH TROUBLE-SHOOTING WAS DONE DUE TO URGENCY TO STOP BLEEDING DURING THE SURGICAL PROCEDURE. A MONOPOLAR ESU ELECTROSURGICAL UNIT WAS ALSO AVAILABLE FOR USE FOR THE REMAINDER OF THE CASE WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCETRIAD ENERGY PLATFORM GEI COVIDIEN VALLEYLAB FORCETRIAD *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR