BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON 120 IEC/SURGITRON 4.0 DUAL

    MDR report key: 1261625 · Received December 11, 2008

    Report

    Report Number
    2428235-2008-00009
    Event Type
    Injury
    Date Received
    December 11, 2008
    Date of Event
    September 24, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K013255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGITRON GENERATOR WAS RETURNED TO ELLMAN FOR TESTING. TO DATE, THE ELECTRODE HAS NOT BEEN RETURNED. THE GENERATOR WAS TESTED BY ELLMAN AND FOUND TO FUNCTION PROPERLY. THE INSTRUCTIONS FOR USE RECOMMENDS THE USE OF CORNEAL SHIELDS FOR SURGICAL PROCEDURES INVOLVING THE EYELID AND THE SURROUND AREA. WE CONCLUDE THIS EVENT RESULTED FROM USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING ROUTINE LEFT PTOSIS SURGERY ON PATIENT AT SETTING 10 CUT, THE SURGITRON APPEARED TO BE SUBJECTED TO A POWER SURGE CAUSING THE USER TO CUT THROUGH SEVERAL LAYERS OF TISSUE AND INTO THE CORNEA. FULL EXAMINATION REVEALED BUTTON HOLING OF ORBICULARIS MUSCLE AND PERFORATION OF THE SUPERIOR TARSAL PLATE. ON COMPLETION OF BILATERAL LID SURGERY, MICROSCOPIC EXAMINATION OF THE CORNEA REVEALED A SMALL FULL THICKNESS PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON 120 IEC/SURGITRON 4.0 DUAL GEI ELLMAN INTERNATIONAL, INC. IEC3A-S30

    Patients

    Seq Age Sex Outcome Treatment
    1 Other