BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZEISS 30 SL/M

    MDR report key: 46651 · Received October 30, 1996

    Report

    Report Number
    2914019-1996-00011
    Event Type
    Other
    Date Received
    October 30, 1996
    Date of Event
    August 16, 1996
    Report Date
    October 25, 1996
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY PERSONNEL DID NOT FOLLOW THE OPERATOR MANUAL INSTRUCTIONS AND; THEREFORE, INCORRECTLY INSTALLED A CO-OBSERVATION TUBE. THE CO-OBSERVATION TUBE WAS INSTALLED ON THE PT SIDE OF THE EYE SAFETY FILTER WHICH PERMITTED UNFILTERED LASER LIGHT THROUGH THE CO-OBSERVATION TUBE INTO PERSONNEL'S EYES. THIS RESULTED IN TWO USER FACILITY PERSONNEL WHO WERE OBSERVING THE PROCEDURE THROUGH THE CO OBSERVATION TUBE, RECEIVING PERMANENT, ALTHOUGH MINOR, DAMAGE TO THEIR VISION. NO MEDICAL INTERVENTION WAS TAKEN. THE PERSONNEL ARE STILL UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEISS 30 SL/M LASER DELIVERY SYSTEM HQF COHERENT MEDICAL GROUP 0613-461-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other