BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4101138 · Received September 19, 2014

    Report

    Report Number
    2937094-2014-00852
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 30, 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

    FAILURE ANALYSIS FOR FIBER 0010-2400-409A-(B)(4): THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE PROXIMAL TO THE BEVEL EDGE; THE DISTAL TIP OF THE FIBER WAS NOT RETURNED; THE FIBER GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE DISTAL TO THE BEVEL EDGE; THE DISTAL TIP OF THE GLASS CAP WAS NOT RETURNED; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITS SEVERE CHAR. 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 AT 162,173 JOULES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER WAS OBSERVED TO EXHIBIT A LOSS OF TISSUE VAPORIZATION EFFICIENCY. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. OUTCOME: NO DAMAGE TO THE PATIENT - THERE WAS NO INJURY REPORTED. GLAND VOLUME: 40 ML; TIME EXPENDED: 21 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584163 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 409A

    Patients

    Seq Age Sex Outcome Treatment
    1