BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER FIBER

    MDR report key: 38867 · Received July 10, 1996

    Report

    Report Number
    38867
    Event Type
    Injury
    Date Received
    July 10, 1996
    Report Date
    July 3, 1996
    Manufacturer
    ECLIPSE SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED DURING A LASER PROCEDURE. THE STAFF STATED "THE LASER FIBER WOULD NOT FIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER FIBER LASER FIBER GEX ECLIPSE SURGICAL TECHNOLOGIES, INC. * LB 037-64-5

    Patients

    Seq Age Sex Outcome Treatment
    1 *