BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON

    MDR report key: 713717 · Received April 14, 2006

    Report

    Report Number
    713717
    Event Type
    Injury
    Date Received
    April 14, 2006
    Date of Event
    January 24, 2006
    Report Date
    March 1, 2006
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PTOSIS THAT INTERFERED WITH HER VISION. SHE WAS SCHEDULED FOR PTOSIS REPAIR AND MID-FACE ELEVATION TO REPAIR LOWER LID POSITIONS. ELLMAN RADIOFREQUENCY UNIT WAS SET ON THE NORMAL SETTINGS AND WAS BEING USED TO CUT THE EYELID SKIN. FIRST ATTEMPT ON THE CUT MODE RESULTED IN AUDIBLE TONE OF THE MACHINE AND NO CUTTING OF THE SKIN. THE BUTTON WAS RELEASED AND REPOSITIONED. TONE WAS AGAIN HEARD AND THERE WAS NO CUTTING OF THE SKIN. ON THE THIRD ATTEMPT, ADDITIONAL PRESSURE WAS APPLIED, THE INSTRUMENT CUT BUT CAUSED A DEEPER THAN EXPECTED CUT AND RESULTED IN A FULL-THICKNESS INCISION AND CENTRAL CORNEAL LACERATION THROUGH THE PUPILLARY AXIS. CORNEAL LACERATION WAS REPAIRED. LONG TERM OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON ESU HANDPIECE GEI ELLMAN INTERNATIONAL, INC. SURGITRON 4.0 DUAL RF *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention| S NO OTHER THERAPIES