BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    920

    MDR report key: 77833 · Received March 13, 1997

    Report

    Report Number
    2914019-1997-00008
    Event Type
    Malfunction
    Date Received
    March 13, 1997
    Date of Event
    January 30, 1997
    Report Date
    March 12, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EYE SAFETY FILTER WAS FOUND TO BE OUT OF SPECIFICATION. THE COHERENT MEDICAL GROUP'S TRANSMISSION SPECIFICATION OF THE FILTER DISC IS LESS THAN .001%. THE OUT OF SPEC FILTER WAS MEASURED 500 MICROWATTS OR .83% TRANSMISSION OF THE RIGHT DISC, AND 300 MICROWATTS OR .5% TRANSMISSION OF THE LEFT DISC. FILTERS THAT HAVE 1% LEAKAGE WOULD STILL KEEP THE LIGHT LEVELS AT THE EYEPIECE EXIT THE CLASS 1 FOR ALL CO LASERS. THEREFORE, THE WATTS DELIVERED DID NOT CAUSE LIGHT IN EXCESS OF 21 CFR 1040 CLASS 1 CRITERIA AND IT WOULD BE EXTREMELY UNLIKELY FOR ANY INJURY TO HAVE OCCURRED WHILE USING THE LASER. AS CORRECTIVE ACTION, COHERENT HAS ADDED INSTRUCTIONS TO CO'S METHODS TO CHECK FOR LIGHT LEAKS WHEN TESTING FILTERS.

    Description of Event or Problem · 1

    TWO DRS COMPLAINED FO FLASHBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 920 OPHTHALMIC LASERS GEX COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN