BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTIMA SE

    MDR report key: 58205 · Received December 15, 1996

    Report

    Report Number
    2914019-1996-00012
    Event Type
    Other
    Date Received
    December 15, 1996
    Date of Event
    October 6, 1996
    Report Date
    December 12, 1996
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    HQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FIELD SERVICE REP RECEIVED UNINTENDED LASER LIGHT EXPOSURE WHILE ATTEMPTING TO TROUBLESHOOT THE LASER. THE LASER WAS NOT LASING WHEN THE FOOTSWITCH WAS DEPRESSED. HE WANTED TO DETERMINE IF THE TUBE WAS "GLOWING". HE PLACED MIRROR BETWEEN THE SECONDARY MIRROR OF THE LASER AND THE PHOTOCELL. HE WAS DEPRESSING THE FOOTSWITCH; THE LASER LASED ONCE AND A REFLECTION OF THE BEAM OFF OF THE MIRROR STRUCK HIM IN THE LEFT EYE. THE INITIAL CALL FOR SERVICE WAS AN "OUT OF BOX" FAILURE. THE LASER WOULD NOT GO THROUGH ITS COUNTDOWN WITHOUT EXHIBITING ERRORS. THE LASER NEVER WAS OPERATIONAL AND WAS NEVER USED BY THE USER FACILITY. THE SERVICE ENGINEER HAD THE COVERS OFF AND THE SERVICE SOFTWARE INSTALLED. THE SERVICE SOFTWARE INTENTIONALLY OVER-RIDES THE SAFETY FUNCTIONS SO THAT THE SERVICE PERSONNEL CAN SERVICE THE LASER. THIS INCIDENT DID NOT CAUSE NOR WOULD NOT CAUSE ANY INJURY TO THE USER FACILITY PERSONNEL, SINCE THEY DO NOT HAVE ACCESS TO THE SERVICE SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMA SE OPHTHALMIC LASER HQF COHERENT MEDICAL LASER GROUP * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other