BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUST-CYLCO-G6

    MDR report key: 11828940 · Received May 14, 2021

    Report

    Report Number
    2939653-2021-00013
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 13, 2021
    Manufacturer
    IRIDEX CORPORATION
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A PATIENT EXPERIENCING SCLERAL BURN DURING TRANSCLERAL CYCLO PHOTOCOAGULATION WITH THE G-PROBE. ENGINEERING ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE PROBE WAS VISUALLY INSPECTED AND THE PRESENCE OF A PARTICLE WAS OBSERVED ON THE TIP OF THE DEVICE. THE PROBE TIP WAS PARTICLE WAS EXAMINED UNDER A MICROSCOPE AND THE PRESENCE OF A BURNT PARTICLE ON THE FIBER TIP WAS OBSERVED. AS NOTED IN THE WARNINGS SECTION OF THE G PROBE INSTRUCTIONS FOR USE, "EXCESSIVE TREATMENT POWER MAY RESULT IN OCULAR SURFACE BURNS OR CILIARY BODY HEMORRHAGE. CONTAMINATION OF THE FIBER OPTIC TIP BY BLOOD OR TISSUE CHAR MAY RESULT IN OCULAR SURFACE BURNS. THE IRIDEX G-PROBE INSTRUCTIONS FOR USE PROVIDES INSTRUCTIONS TO THE USER TO EXAMINE THE TIP OF THE DEVICE TO MAKE SURE NO BLOOD OR OTHER CONTAMINANTS ARE PRESENT. A FOLLOW-UP WITH THE PATIENT WAS COMPLETED AND THE PATIENT HAS COMPLETELY RECOVERED WITHOUT ANY ADDITIONAL INTERVENTION. THE REVIEW OF COMPLAINT HISTORY INDICATED THAT THIS ISSUE IS NOT PART OF AN INCREASING TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722754 CUST-CYLCO-G6 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF IRIDEX CORPORATION 11256-1 900290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other