BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-PROBE SINGLE

    MDR report key: 5541684 · Received April 1, 2016

    Report

    Report Number
    2939653-2016-00002
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    January 21, 2016
    Report Date
    March 30, 2016
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K022228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT REPORTED WITHIN 30 DAYS DUE TO ESG WEBTRADER ACCOUNT DIFFICULTIES.

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING DIODE LASER TO THE LEFT EYE. SETTINGS ON LASER MACHINE WERE SET BY THE PHYSICIAN. DURING THE PROCEDURE, PHYSICIAN WAS USING A G-PROBE (11256-1, LOT # 016108) THAT CONNECTS TO THE LASER AND NOTICED SMALL CONJUNCTIVAL BURNS APPROXIMATELY 1MM IN SIZE MEDIAL AND LATERAL. NO CENTRAL BURNS WERE NOTED. PHYSICIAN STOPPED PROCEDURE AND ASKED FOR REPLACEMENT G-PROBE. THE LASER PROCEDURE CONTINUED AND WORKED WITHOUT INCIDENT. PATIENT'S EYE GIVEN MAXTROL 00 AND DRESSED WITH EYE PADS, EYE SHIELD AND PAPER TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196843 G-PROBE SINGLE LASER DEVICE GEX IRIDEX CORPORATION 016108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other