BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON

    MDR report key: 1206057 · Received October 21, 2008

    Report

    Report Number
    2428235-2008-00005
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    March 30, 2007
    Report Date
    September 26, 2008
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    HQR
    PMA / PMN Number
    K955158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVEN'T BEEN ABLE TO CONFIRM THE SERIAL NUMBER, HOWEVER, OUR RECORDS INDICATE THAT THE PHYSICIAN HAS A SURGITRON FFPF OHTHALMOLOGY, MANUFACTURED PRIOR TO YEAR 2002.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT HE WAS PERFORMING A BLEPHORPLASTY ROUGHLY 18 MOS AGO. AT THE END OF THE PROCEDURE, HE REALIZED THAT HE HAD CUT THROUGH THE PT'S CORNEA DURING THE PROCEDURE. HE STATED THAT THERE WAS NOTHING WRONG WITH HIS SURGITRON, HE SIMPLY CUT TOO DEEP. THE PT REQUIRED A CORNEA TRANSPLANT AND NOW HAS 20/20 VISION. THE DOCTOR HAS CONTINUED TO PERFORM BLEPHORPLASTY PROCEDURES WITH HIS SURGITRON FOLLOWING THE ACCIDENT 18 MOS AGO. THE INSTRUCTIONS FOR USE STATE THAT EYE SHIELDS SHOULD BE USED WHEN PERFORMING BLEPHORPLASTY PROCEDURES. THE PHYSICIAN WAS ENCOURAGED TO USE CORNEAL SHIELDS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON HQR ELLMAN INT'L INC. FFPF OPHTHALMOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention