BEUDAMED
    FDA Adverse Event Summary report: N

    CONMED ELECTROCAUTERY PENCIL

    MDR report key: 566819 · Received January 10, 2005

    Report

    Report Number
    MW1034367
    Date Received
    January 10, 2005
    Date of Event
    November 2, 2004
    Report Date
    January 10, 2005
    Manufacturer
    CONMED CORP
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR HAS EXPERIENCED PROBLEMS WITH AN ELECTROCAUTERY PENCIL PACKAGED IN STERILE CUSTOM PACKS FROM CARDINAL HEALTH. THE PRODUCT IS A CONMED ELECTROCAUTERY PENCIL # 131318, 130318 AND ALSO THE STERILE VERSION 130309. THE PROBLEM IS THE PUSH BUTTON DEVICE STICKS IN THE "ON" POSITION. THE INITIAL INCIDENT CAUSED AN ACTUAL BURN IN THE STERILE DRAPE IN THE OR AND AN INCIDENT REPORT WAS FILED RPTR CONTACTED CARDINAL AND GAVE THEM THE FAULTY PRODUCT. RPTR ALSO GAVE THE LOCAL CONMED REP. SEVERAL PENCILS THAT FAILED AFTER THE INITIAL INCIDENT. IT HAS BEEN THREE MONTHS AND CONMED HAS NOT FOLLOWED UP. RPTR HAS HAD THREE MORE FAILURES THIS PAST WEEK. CONMED ALSO ADMITTED TO FINDING A PROBLEM WITH THE SOLDER JOINT. RPTR CONTINUES TO HAVE PROBLEMS. RPTR HAS STOPPED USING THE PENCIL AND SWITCHED TO ANOTHER MFR. RPTR WISHES THIS TO BE MORE CRITICALLY EVALUATED. FIRES IN THE OPERATING ROOM CAN BE LIFE THREATENING TO PT AND STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROCAUTERY PENCIL * GEI CONMED CORP 130309 *
    2 CONMED ELECTROCAUTERY PENCIL * GEI CONMED CORP 131318 *
    3 CONMED ELECTROCAUTERY PENCIL * GEI CONMED CORP. 130309 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *