BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 1963004 · Received January 14, 2011

    Report

    Report Number
    1963004
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 14, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT NO LONGER REQUIRED CHEMOTHERAPY AND SO THE POWERPORT CATHETER WAS SCHEDULED TO BE SURGICALLY REMOVED. THE PATIENT'S RIGHT SHOULDER WAS PREPPED WITH POVIDONE SCRUB AND OXYGEN WAS BEING ADMINISTERED VIA A REBREATHER MASK. WHILE THE PHYSICIAN BEGAN DIVIDING THE SUBCUTANEOUS TISSUE WITH A CAUTERY, THE STAFF NOTICED A FLAME NEAR THE SITE OF THE INCISION. THE PHYSICIAN IMMEDIATELY STOPPED USING THE CAUTERY AND IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT (OR STAFF). THE SETTINGS ON THE ELECTROSURGERY UNIT (ESU) WERE CHANGED FROM 35 COAG/50 CUT TO 20/0 WITH NO FURTHER INCIDENT. AFTER THE PROCEDURE THE ESU AND ACCESSORIES WERE SENT TO BIOMEDICAL ENGINEERING FOR AN EVALUATION.FOLLOW UP: THE ESU WAS TESTED AND ALL READINGS WERE WITHIN THE NORMAL LIMITS. TESTED AT BOTH 35/50 AND 20/1 AND UNIT WORKED FINE. THE DISPOSABLE HANDPIECE DID HAVE A BUILD UP OF DEBRIS AND THERE WAS BURNED RESIDUAL ON THE DISTAL OF THE HANDPIECE TIP. THE REM PAD WAS INSPECTED AND THIS WAS UNREMARKABLE. THE ESU CART POWER CORD WAS HOT AND THE NEUTRAL WIRES WERE LOOSE WITHIN THEIR RETAINERS (PULLED OUT WITH MINIMAL EFFORT). THE WIRES WERE TIGHTENED. AN ELECTRICAL SAFETY CHECK WAS PERFORMED AND THE GROUND CORD RESISTANCE READING WAS AT .902 OHMS. THE POWER CORD WAS RESEATED AT THE ESU POWER INLET MODULE. GROUND TESTED O.K. THE TECHNICIAN AGGRESSIVELY FLEXED THE POWER CORD AND NO FLUCTUATION NOTED IN THE GROUND CORD RESISTANCE. THE GROUND TESTED WITHIN NORMAL LIMITS. THE ESU WAS PLACED BACK IN SERVICE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX ELECTROSURGICAL GENERATOR GEI COVIDIEN VALLEYLAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR