BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3902039 · Received June 30, 2014

    Report

    Report Number
    2937094-2014-00561
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 1, 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
    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 SEVERE DEVITRIFICATION AT OUTPUT WINDOW; THE METAL CAP EXHIBITS MODERATE CHAR; THE FIBER WITHIN THE OUTER FLOW TUBING PROXIMAL TO THE GLASS CAP GLUE ZONE IS CONTAMINATED AND MELTED. 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, THE FIBER BROKE @ 350,000 JOULES AND 60 MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THERE WERE "NO DAMAGES TO THE PATIENT" REPORTED. GLAND VOLUME 70 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380634 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 345A

    Patients

    Seq Age Sex Outcome Treatment
    1