BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOSCOPE EYE FILTER

    MDR report key: 141114 · Received December 30, 1997

    Report

    Report Number
    2937094-1997-00016
    Event Type
    Other
    Date Received
    December 30, 1997
    Date of Event
    October 6, 1997
    Report Date
    October 21, 1997
    Manufacturer
    LASERSCOPE
    Product Code
    GCT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN USING KTP, THE SYSTEM GAVE WARNING THAT THE EPF WAS NOT ATTACHED. THE LASER WAS SET TO 30 WATTS, ALLEGEDLY THE PHYSICIAN SAW A GREEN FLASH OF LIGHT THROUGH THE SCOPE AND EYE PROTECTION FILTER. IT APPEARS THAT THE DEVICE WAS NOT CONNECTED TO THE LASER AND WAS MANUALLY HELD IN PLACE BY THE PHYSICIAN. THE CUSTOMER DID NOT WANT IN-SERVICE OF LASER OR EPF. CLINICAL IN-SERVICE WILL BE CONDUCTED BY LASERSCOPE. SYSTEM LABELING FOR EPF ALWAYS ALERTS THE OPERATOR OF THE EPF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPE EYE FILTER LASER ACCESSORIES GCT LASERSCOPE 10-0433 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other