BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 210954 · Received February 17, 1999

    Report

    Report Number
    1720381-1999-00002
    Event Type
    Malfunction
    Date Received
    February 17, 1999
    Date of Event
    January 27, 1999
    Report Date
    February 10, 1999
    Manufacturer
    FISMA
    Product Code
    LQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING MICROSURGERY PROCEDURE, SHUTTER FAILED TO CLOSE WHEN LASER FIRED. PHYSICIAN REPORTED SEEING LIGHT BEAM THROUGH SCOPE. PHYSICIAN STOPPED PROCEDURE, PUT ON SAFETY GLASSES AND COMPLETED PROCEDURE. FIELD SERVICE ENGINEER WAS CONTACTED DIRECTLY BY A PURCHASING REP FOR THE USER FACILITY BY REQUEST OF THE OPERATING ROOM SUPERVISOR. PHYSICIAN REPORTED TO FIELD SERVICE ENGINEER THAT NO INJURY TO SELF OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM ARGON MICROFILTER LQJ FISMA K10-A-K03-1-73 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other