BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED

    MDR report key: 1192465 · Received October 1, 2008

    Report

    Report Number
    1720159-2008-00026
    Event Type
    Injury
    Date Received
    October 1, 2008
    Date of Event
    June 23, 2008
    Report Date
    September 2, 2008
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    k791137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LAB TESTING OF THE DEVICE LISTED IN THE REPORT (S) INCLUDING: A COMPLETE DESCRIPTION OF METHODOLOGY (IES) USED: THE RETURNED DEVICE WAS VISUALLY INSPECTED AND NO OBVIOUS NON CONFORMANCES WERE IDENTIFIED. THE RETURNED PENCIL WAS CONNECTED TO AN ELECTROSURGICAL UNIT. THE DEVICE WAS ACTIVATED AND OPERATED IN ALL MODES. AN IDENTIFICATION OF THE FAILURE MODE (S) AND/OR MECHANISM (S) AND THE ASSOCIATED COMPONENT (S) INVOLVED: THE RETURNED DEVICE WAS ACTIVATED AND OPERATED IN ALL MODES. THE RETURNED DEVICE FUNCTIONED AS INTENDED. ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LAB TEST RESULTS: THE RETURNED DEVICE FUNCTIONED AS INTENDED. ANY EVAL OF THE INCIDENT DESCRIBED IN THE MEDICAL DEVICE REPORT BY THE ATTENDING PHYSICIAN, SURGEON, HOSP REP OR THE HLTH CARE PROFESSIONAL: NO ADD'L INFO IS AVAILABLE FROM THE ATTENDING PHYSICIAN, SURGEON, HOSP REP OR THE HLTH CARE PROFESSIONAL. MORE COMPLETE INFO CONCERNING THE PT INCLUDING AGE, SEX AND MEDICAL HISTORY: THE USER FACILITY WAS ONLY ABLE TO PROVIDE THE SEX OF THE PT; FEMALE.

    Description of Event or Problem · 1

    SUPERFICIAL 2 MM BURN SUSTAINED TO PT'S RIGHT RING FINGER. GREENVILLE HOSP INSTRUCTED PARENTS OF PT TO APPLY OINTMENT TO THE BURN. THE PT WAS RELEASED WITHOUT ADD'L PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL/BOVIE GEI CONMED ELECTROSURGERY * 0804242

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other