BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM BIOMEDICAL, INC.

    MDR report key: 414284 · Received August 29, 2002

    Report

    Report Number
    MW1026025
    Event Type
    Malfunction
    Date Received
    August 29, 2002
    Date of Event
    August 22, 2002
    Report Date
    August 29, 2002
    Manufacturer
    CONTINUUM BIOMEDICAL, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHOTO DIODE MIRROR CAME UNGLUED SO ENERGY WAS ALLOWED TO EXIT THE LASER ARM BEFORE STEPPING ON THE FOOTPEDAL. THERE WAS NO INJURY TO EITHER THE PT OR STAFF IN THE ROOM.

    Description of Event or Problem · 1

    ADD'L MFR INFO REC'D IN 04/10/2003: THERE IS A BEAM SHUTTER WITHIN THE UNIT THAT BLOCKS LASER RADIATION FROM EXITING THE UNIT DURING CALIBRATION AND/OR CHANGING OF THE LASER WAVELENGTH. IN MAY OF 1993 THIS SHUTTER WAS MODIFIED. A SMALL HOLE WAS ADDED TO THE SHUTTER TO HELP DISSIPATE HEAT FROM THE BEAM DUMP PAD. THE BEAM DUMP PAD WAS ATTACHED TO THE INTERNAL SURFACE OF THE SHUTTER WITH AN ADHESIVE EPOXY. THERE WERE 25 DOMESTIC LASERS AND 1 KOREAN LASER AFFECTED BY THIS CHANGE. THOUGH THERE WERE NO FAILURES OR PROBLEMS ASSOCIATED WITH THE USE OF EPOXY AT THE TIME, A SUBSEQUENT CHANGE PHYSICALLY ATTACHED THE SHUTTER AND BEAM DUMP PAD AND THE USE OF EPOXY WAS ELIMINATED. THIS CHANGE OCCURRED IN SEPTEMBER OF 1993. THIS DESIGN CHANGE WAS INTENDED TO PRECLUDE ANY ISSUES ASSOCIATED WITH THE USE OF EPOXY ADHESIVE. DURING THE SUBSEQUENT 10 YEARS, THE AFFECTED 26 LASER UNITS BUILT USING EPOXY EXPERIENCED A SINGLE INSTANCE OF THE BEAM DUMP PAD COMING LOOSE FROM THE SHUTTER. IN AN EFFORT TO ASSURE THAT ANY REMAINING LASERS AFFECTED BY THE USE OF EPOXY ADHESIVE ARE IDENTIFIED AND CORRECTED, CONBIO IS CALLING AND SENDING A LETTER TO THE INDIVIDUALS AND INSTITUTIONS THAT PURCHASED THESE LASERS. THE UNITS, IF STILL IN SERVICE, ARE BEING FIELD UPGRADED BY REPLACEMENT OF THE BEAM SHUTTER MECHANISM TO ELIMINATE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUUM BIOMEDICAL, INC. Q-SWITCHED YAG LASER GEX CONTINUUM BIOMEDICAL, INC. MEDLITE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *