BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 400077 · Received June 12, 2002

    Report

    Report Number
    1720381-2002-00004
    Event Type
    Malfunction
    Date Received
    June 12, 2002
    Date of Event
    May 20, 2002
    Report Date
    May 20, 2002
    Manufacturer
    FISMA
    Product Code
    LQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR STARTED THE PROCEDURE AND THE FIRST TIME HE FIRED THE LASER HE REPORTED SEEING A GREEN FLASH OF LIGHT. FOR THE REST OF THE PROCEDURE HE WORE SAFETY FILTER GLASSES AND COMPLETED THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. LATER THE DOCTOR WAS CHECKED BY THE OPHTHALMOLOGY DEPARTMENT OF THE CLINIC AND NO INJURY WAS FOUND . BIO-TECH REPORTED THAT THERE WERE NO ERROR CODES INDICATING A FAULT CONDITION IN THE LASER SYSTEM DURING THE PROCEDURE. LATER IN THE DAY THE SHUTTER WAS CAUSED TO MALFUNCTION BY CLINIC STAFF AND AN ERROR CODE DID PREVENT THE LASER FROM FIRING. THE DEVICE THEN WAS PACKAGED AND RETURNED TO MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM MICROSCOPE LASER FILTER LQJ FISMA K10-A-K08-1-73 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *