BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTROSURGICAL UNIT -ESU-

    MDR report key: 1887582 · Received October 27, 2010

    Report

    Report Number
    MW5017964
    Event Type
    Other
    Date Received
    October 27, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 27, 2010
    Manufacturer
    VALLEY LAB
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING C-SECTION, SURGICAL TECH ASSISTANT WAS ASSISTING OBSTETRICIAN BY PUSHING DOWN ON UPPER ABDOMEN TO HELP MOVE NEWBORN DOWN, THE BOVIE PENCIL WAS EITHER OUT OF THE HOLDER OR DROPPED OUT OF THE HOLDER AND ACTIVATED, AND BURNED THROUGH THE DRAPE AND CAUSED A HALF DOLLAR SIZE BURN TO PT'S UPPER RIGHT ABDOMEN. ON 10/22/2010, BIOMEDICAL REPORT: TESTED ALL FUNCTIONS OF THE ESU WITH NO ERRORS OCCURRING. UNIT OPERATED AS DESIGNED WITHOUT FAILURE. TESTED CUT, COAG AND BIPOLAR TONES. TONES GOOD. VOLUME GOOD. TESTED CUT OUTPUT: 300=307; 100=102; 50=52 WATTS. TESTED COAG OUTPUT: 120=111; 50=49; 25=24 WATTS. TESTED BIPOLAR OUTPUT: 70=71; 20=17, TESTED FOOTSWITCH THAT IF BOTH PEDALS WERE PRESSED AT THE SAME TIME COAG ACTIVATES, OK TESTED REM ALARM, OK. ESI 11 OHMS 40UA. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: CAUTERIZE VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL UNIT -ESU- BOVIE GEI VALLEY LAB FXC

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other