BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3894511 · Received June 25, 2014

    Report

    Report Number
    2937094-2014-00551
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 6, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE METAL CAP EXHIBITS SEVERE CHAR; 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 METAL CAP ADHESION LOCATION EXHIBITS BURNT GLUE; THE OUTER FLOW TUBING EXHIBITED MILD 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 @ 390,000 JOULES AND 52:38 MINUTES OF USE THE FIBER STOPPED WORKING. THE PROCEDURE WAS COMPLETED BY ALTERNATE PROCEDURE. . ¿NO DAMAGED TO THE PATIENT¿ WAS REPORTED. GLAND VOLUME 80 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371857 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