BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3994166 · Received August 8, 2014

    Report

    Report Number
    2937094-2014-00704
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/GLASS CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE GLASS CAP AND THE METAL CAP ARE DETACHED AND RETURNED; THE GLASS FIBER EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE GLASS CAP EXHIBITS VERY MILD DETRITUS ADHESION. BASED ON THE ANALYSIS, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBERS METAL CAP CAME OFF. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. THERE WAS NO PATIENT INJURY REPORTED. GLAND VOLUME: 100 ML. TIME EXPENDED: 29:09. JOULES USED: 140,062.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467324 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 350B

    Patients

    Seq Age Sex Outcome Treatment
    1