BEUDAMED
    FDA Adverse Event Summary report: N

    EMPIRE MICROINCISION ELECTRODE

    MDR report key: 2222682 · Received July 25, 2011

    Report

    Report Number
    2428235-2011-00001
    Date Received
    July 25, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ELLMAN INTERNATIONAL'S QTEE13 ELECTRODE WAS USED WITH A VALLEYLAB FORCE FX ELECTROSURGICAL GENERATOR. WE WERE TOLD THAT THE POWER SETTING FOR THIS PROCEDURE WAS BETWEEN 12 - 15 WATTS. THE PROCEDURE LASTED FOR 30 MINUTES. A METAL RETRACTOR WAS ALSO USED DURING THE PROCEDURE. THE RETURNED ELECTRODE WAS EXAMINED UNDER MAGNIFICATION. THERE IS A THIN V-SHAPED CUT IN THE ELECTRODE INSULATION THAT APPEARS TO HAVE BEEN CAUSED BY A SCALPEL OR SHARP EDGE OF A SURGICAL RETRACTOR. THIS CUT IS LOCATED WHERE THE INSULATED SHAFT OF THE ELECTRODE WAS IN CONTACT WITH THE PT'S MOUTH LEADING TO THE INJURY. WE BELIEVE THIS DAMAGE TO THE ELECTRODE OCCURRED DURING THE SURGICAL PROCEDURE. NOTHING IN OUR PRODUCTION PROCESS COULD CAUSE THE CUT OBSERVED. THERE IS NO HISTORY OF PRIOR CUSTOMER COMPLAINTS NOR ARE THERE ANY IN-PROCESS REJECTIONS FOR SUCH DAMAGE. WE HAVE REVIEWED PRODUCT IN PRODUCTION AND HAVE FOUND NO EVIDENCE OF SUCH DAMAGE.

    Description of Event or Problem · 1

    DURING AN AMYGDALECTOMY PROCEDURE, AN ADULT PT SUFFERED A 3RD DEGREE BURN ON THE RIGHT SIDE OF THE UPPER LIP, CLOSE TO THE CORONER OF HIS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRE MICROINCISION ELECTRODE GEI ELLMAN INTERNATIONAL, INC. QTEE313 36976

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention