BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3931516 · Received July 14, 2014

    Report

    Report Number
    2937094-2014-00609
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 5, 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 FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP EXHIBITS MILD DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MILD CHAR; THERE IS NO SIGN OF THE BEAM FIRING INSIDE THE METAL CAP; THE STOP SIGN ON THE OUTER FLOW TUBING IS NOT ALIGNED WITH METAL CAP OUTPUT WINDOW; THE METAL CAP CAN ROTATE FREELY WITHIN THE OUTER FLOW TUBING. BASED ON THE ANALYSIS ABOVE, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, AT 1663 JOULES 54 SECONDS THE CONSOLE STOPPED WORKING. THE FIBER WAS EXCHANGED AND COMPLETED CASE WITH THE SECOND FIBER. PATIENT OUTCOME: "NO DAMAGES TO THE PATIENT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409377 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