BEUDAMED
    FDA Adverse Event Other Summary report: N

    925

    MDR report key: 123984 · Received September 29, 1997

    Report

    Report Number
    2914019-1997-00027
    Event Type
    Other
    Date Received
    September 29, 1997
    Date of Event
    August 27, 1997
    Report Date
    August 27, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H3 - IT CANNOT BE DETERMINED WHAT ACTUALLY CAUSED THE EVENT. MOST PROBABLE CAUSE WAS CONATMINATION. CONTAMINATION WAS FOUND AT 100 X MAGNIFICATION AND THEREFORE MINUTE. THE ANALYSIS OF THE FIBER SHOW LOW TRANSMISSION AND BEAM NEEDING ALIGNMENT. COHERENT'S FIELD SERVICE ENGINEER CHECKED THE LASER ON THE SAME DAY THE INCIDENT HAPPENED AND COULD NOT FIND ANY PROBLEMS WITH THE FIBER, THE LASER OR THE CALIBRATION. ALL SAFETY CIRCUITS WERE FUNCTIONING PROPERLY. FIBERS ARE 100% INSPECTED FOR TRANSMISSION BEFORE THEY LEAVE THE PLANT. RECORDS SHOW THIS FIBER WAS WITHIN SPECIFICATION WHEN IT WAS MFG.

    Description of Event or Problem · 1

    AT 500 MICRON SPOT SIZE IN GREEN, DOCTOR HAD TO INCREASE POWER AND TIME TO GET ANY BURN. DOCTOR REPORTED SEEING A DOUGHNUT SHAPED BEAM. SUDDENLY HE GOT A SURGE OF POWER CAUSING AN EXCESS TEAR AND HEMORRHAGE. WHEN THIS HAPPENED THE DOCTOR NOTICED THAT THE DOUGHNUT SHAPE WAS GONE. RESULT: RETINAL TEAR AND SMALL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 925 ARGON LASER GEX COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN