BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEY LAB

    MDR report key: 2900755 · Received December 17, 2012

    Report

    Report Number
    2900755
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    October 10, 2012
    Report Date
    December 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY VALLEY LAB, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US

    Narratives

    Description of Event or Problem · 1

    FORCE TRIAD MACHINE SET VIA ACCESSORY SCREEN: CUT -15 AND COAG - 15 WITH A BLEND/SPRAY FEATURE. TIME OUT DONE AND ALL VERBALIZED THE SETTINGS ON MACHINE WERE CORRECT. AFTER DRAPING THE PATIENT, THE CAUTERY PENCIL WAS PLUGGED INTO THE MACHINE. THE CAUTERY WAS USED ON THE PATIENT; PENCIL IMMEDIATELY SPARKED AND USE DISCONTINUED. MINOR BURN TO PATIENT'S ABDOMEN OCCURRED, REQUIRING OINTMENT TREATMENT. THE MACHINE RECOGNIZED THE PENCIL AS A MONOPOLAR CAUTERY CORD CONNECTED AND AUTOMATICALLY SWITCHED TO MONOPOLAR SCREEN (NOT THE ACCESSORY SCREEN THAT WAS SET FOR THIS PROCEDURE). THE MONOPOLAR SCREEN WAS STILL SET FROM A PREVIOUS CASE AT CUT - 190 AND COAG - 60. THIS CAUTERY PENCIL IS A BIPOLAR ACCESSORY AND SHOULD NOT HAVE TURNED ON THE MONOPOLAR POWER. ALTHOUGH OPERATOR ERROR MAY HAVE CONTRIBUTED TO THE EVENT, IT IS CONFUSING TO USERS TO HAVE THE SCREENS THE SAME COLOR AND AN AUTOMATIC DEFAULT TO PREVIOUS SETTINGS WHEN THE CAUTERY PENCIL IS PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEY LAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, FORMERLY VALLEY LAB, A DIVISION OF TYCO HEALTHCARE FORCE TRIAD ENERGY PLATFORM *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR NO OTHER THERAPIES