BEUDAMED
    FDA Adverse Event Summary report: N

    CONMED PENCIL 130309

    MDR report key: 900611 · Received October 19, 2006

    Report

    Report Number
    1720159-2006-00049
    Date Received
    October 19, 2006
    Date of Event
    September 22, 2006
    Report Date
    October 19, 2006
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PENCIL WAS SPLIT OPEN TO DETERMINE THE CAUSE OF THE MELTED PENCIL BODY. THE BLADE ELECTRODE WAS NOT INSERTED FAR ENOUGH INTO THE PENCIL BODY TO ALLOW CONTACT WITH THE PENCIL'S INTERNAL COLLET. ANY BLADE INSERTED INTO A ELECTROSURGICAL PENCIL MUST BE PUSHED IN FAR ENOUGH TO ALLOW RF CURRENT TO EASILY PASS FROM THE PENCIL TO THE SHAFT OF THE BLADE. NOT DOING THIS CAUSES A GAP RF CURRENT MUST JUMP ACROSS WHICH CREATES INTENSE HEAT. THE HEAT CAN BE HOT ENOUGH TO MELT THE PENCIL'S BODY.

    Description of Event or Problem · 1

    THE PENCIL WAS ARCING INSIDE AND MELTED THE PLASTIC PENCIL BODY. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED PENCIL 130309 ELECTROSURGICAL PENCIL GEI CONMED ELECTROSURGERY * 060712

    Patients

    Seq Age Sex Outcome Treatment
    1 *