BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER PROBE

    MDR report key: 403695 · Received July 2, 2002

    Report

    Report Number
    2028159-2002-00172
    Event Type
    Malfunction
    Date Received
    July 2, 2002
    Date of Event
    April 5, 2002
    Report Date
    April 10, 2002
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED A PIECE OF LASER FIBER FELL FROM PROBE WHILE LASERING THE RETINA; USED DIAMOND FORCEPS TO REMOVE FIBER. SURGEON FELT THIS COULD CAUSE INJURY IF IT RECURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER PROBE PROBE HQF ALCON-IRVINE TECHNOLOGY CENTER NA 1017357X

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR