BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON 4.0 DUAL RF

    MDR report key: 1586189 · Received January 22, 2010

    Report

    Report Number
    2428235-2010-00002
    Event Type
    Injury
    Date Received
    January 22, 2010
    Date of Event
    July 15, 2008
    Report Date
    December 23, 2009
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K013255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR BECAME AWARE OF THIS EVENT WHEN THE ATTORNEY FOR THE USER FACILITY CONTACTED ELLMAN ASKING FOR INFO TO SUPPORT THEIR INVESTIGATION OF THE EVENT. THE ATTORNEY ADVISED ELLMAN THAT THERE IS NO CLAIM AGAINST THE SURGITRON, ACCESSORIES OR COMPANY. WE ASKED TO HAVE THE SURGITRON AND THE ELECTRODE USED FOR THE PROCEDURE RETURNED FOR EVALUATION. WE HAVE NOT BEEN PROVIDED WITH EITHER. THE E3D SINGLE USE ELECTRODE WAS DISCARDED FOLLOWING THE SURGERY. THE E3D ELECTRODE IS A SCALPEL ELECTRODE, USED FOR CUTTING AND COAGULATION. ELLMAN OFFERS A DIFFERENT ELECTRODE SPECIFICALLY FOR MATRIXECTOMY PROCEDURES. THE PROCEDURE PERFORMED ON THIS PT WAS DONE WITH A DIFFERENT ELECTRODE, HIGHER POWER LEVEL, A DIFFERENT WAVE FORM AND LONGER TREATMENT TIME THAN RECOMMENDED IN LABELING AND PUBLISHED LITERATURE FOR MATRIXECTOMY PROCEDURES.

    Description of Event or Problem · 1

    IN 2008, PT'S INGROWN TOE NAIL ON HER LEFT GREAT TOE WAS REMOVED USING BLUNT DISSECTION WITHOUT DIFFICULTY FOLLOWED BY TREATING THE MATRIX WITH THE SURGITRON DUAL RF GENERATOR AND AN E3D SCALPEL ELECTRODE. THE PHYSICIAN ASSISTANT PERFORMING THE PROCEDURE USED SWEEPING MOTION UTILIZING A CUT COAG WAVEFORM, MEDIAL TO LATERAL AND BACK TWICE, FOR 6 SECONDS TOTAL, STARTING WITH A SETTING OF 25, AND THEN INCREASED TO A SETTING OF 35 IN ORDER TO DESTROY THE MATRIX. ONE WEEK LATER, THE PT RETURNED FOR F/U. THE TOENAIL BED WAS OBSERVED TO BE HEALING WELL. ONE WEEK LATER, THE PT RETURNED FOR ANOTHER CHECK DUE TO SEVERE PAIN. THE PT HAD A LOCALIZED BULLOUS INFECTION WHICH THE PHYSICIAN ASSISTANT ASSOCIATED WITH POST-OPERATIVE EVENTS, BUT NOT ASSOCIATED WITH A WOUND INFECTION AS A RESULT OF THE NAIL REMOVAL. THREE DAYS LATER, A THIRD PARTY PHYSICIAN EXAMINED THE TOE AND DIAGNOSED A 3RD DEGREE BURN AND GANGRENE INFECTION. OVER THE ENSUING MONTHS, THE PT WENT THROUGH SURGERY AND TREATMENTS, ULTIMATELY LEADING TO AN AMPUTATION OF THE TOE AT THE IT JOINT IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON 4.0 DUAL RF GEI ELLMAN INT'L INC. IEC3A-S30

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Disability