BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23-27 GAUGE; STEPPED ANGLED 45 DEGREES ENDOPROBE

    MDR report key: 1262957 · Received December 11, 2008

    Report

    Report Number
    2939653-2008-00001
    Event Type
    Injury
    Date Received
    December 11, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE PROBES FROM LOT# 012543, WERE RETURNED TO IRIDEX FOR EVALUATION. VISUAL INSPECTION OF THE FIRST PROBE REVEALED A BENT NEEDLE. THE FIBER EDGE AT THE NEEDLE APPEARED TO BE SCRATCHED. THE AIM BEAM WAS VERY DIM AND THERE WAS NO POWER OUTPUT. VISUAL INSPECTION OF THE SECOND PROBE REVEALED TISSUE DEBRIS AROUND THE FIBER AND ON THE FACE OF THE FIBER. THE POWER OUTPUT MEASURED 184MW. VISUAL INSPECTION OF THE THIRD AND FINAL PROBE REVEALED A SMALL BURN AT THE CONNECTOR END OF THE FIBER. THE DEVICE WAS NOT RECOGNIZED BY THE LASER TEST CONSOLE. IT WAS ALSO NOTED THAT THE FIBER WAS BROKEN. THE CAUSE OF THE ALLEGED BURN TO THE PATIENT'S EYE COULD NOT BE DETERMINED. REPEATED ATTEMPTS TO CONTACT THE USER FACILITY TO OBTAIN FURTHER EVENT DETAILS AS WELL AS THE CURRENT CONDITION OF THE PATIENT WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO IRIDEX CORPORATION THAT AFTER FEW SHOTS AT 1200-1400 MW USING AN OCULIGHT SLX LASER SYSTEM, THE PHYSICIAN OBSERVED THROUGH THE MICROSCOPE THAT THE PROBE ENDING BURNED INSIDE THE EYE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 23-27 GAUGE; STEPPED ANGLED 45 DEGREES ENDOPROBE 23-27 GA; STEPPED ANGLED 45 DEGREES ENDOPROB GEX IRIDEX CORPORATION 14400-1 012543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OCULIGHT SLX LASER SYSTEM