BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3863559 · Received June 10, 2014

    Report

    Report Number
    2937094-2014-00473
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS DOES NOT SUPPORT THE REPORTED ISSUE OF FIBER HEAD BROKEN. FAILURE ANALYSIS FOR FIBER (B)(4): THE METAL CAP EXHIBITS SEVERE CHAR; THE METAL CAP EXHIBITS MELTED METAL AT THE OUTPUT WINDOW; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP IS LOOSE FROM THE GLASS CAP; THE GLASS CAP CAN ROTATE FREELY WITHIN THE METAL CAP; THE GLASS CAP HAS PUSHED FORWARD IN METAL CAP AND CAN ROTATE OFF CENTER; THE METAL CAP ADHESION LOCATION EXHIBITS BURNT GLUE; THE OUTER FLOW TUBING EXHIBITS SEVERE CONTAMINATION, LIKELY BIOLOGIC. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH WOULD LIMIT THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER HEAD BROKE @ 84,863 JOULES. GLAND VOLUME 50 ML. TIME EXPENDED 13:54 MINUTES.THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337771 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 405A

    Patients

    Seq Age Sex Outcome Treatment
    1