BEUDAMED
    FDA Adverse Event Summary report: N

    CONMED HAND CONTROLLED BOVIE

    MDR report key: 2858029 · Received November 29, 2012

    Report

    Report Number
    MW5027925
    Date Received
    November 29, 2012
    Date of Event
    July 6, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CONMED
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE BOVIE SET AT 17 AND SPRAY DURING A TONSILLECTOMY AND ADENOIDECTOMY CASE AFTER ABOUT 20 SECONDS THE BOVIE TIP SPARKED. THE SURGEON REMOVED IT FROM THE MOUTH. HE STATED THAT HE SAW A SPARK. THEN A SMALL FLAME. THE BOVIE TIP WAS REPLACED USING THE SAME HANDPIECE TO FINISH THE CASE AND CONMED MACHINE. THE OPERATING ROOM MANAGER WAS NOTIFIED IMMEDIATELY. NO INJURIES WERE NOTED BY THE SURGEON. ITEMS USED DURING THE PROCEDURE INCLUDED THE FOLLOWING: CONMED HAND CONTROLLED BOVIE (B)(4), LOT #120330-3, EXP DATE: 03/2017; CONMED NEEDLE TIP (B)(4), LOT #1203301, EXP DATE: 03/2017; COVIDIEN 5.5 MALLINCKRODT ORAL CUFFED TRACHEAL TUBE, LOT #120301-498X, EXP DATE: 03/2017; CONMED SYSTEM (B)(4). THIS UNIT WAS REMOVED FROM SERVICE AND INSPECTED BY INTERNAL BIOMEDICAL STAFF AND FOUND NO APPARENT DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED HAND CONTROLLED BOVIE BOVIE GEI CONMED 130307A 120330-3
    2 CONMED NEEDLE TIP NEEDLE TIP GEI CONMED 138105 1203301
    3 COVIDIEN 5.5 MALLINCKRODT ORAL CUFFED TRACHEAL TUBE ENDOTRACHEAL TUBE LNZ COVIDIEN 120301-498X
    4 CONMED SYSTEM 50001 SYSTEM GEI CONMED 50001

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other