BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4212941 · Received October 30, 2014

    Report

    Report Number
    2937094-2014-00985
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 3, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER GLASS CAP 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 THE OUTPUT WINDOW; THE METAL CAP EXHIBITS SEVERE CHAR; THE METAL CAP IS DEFORMED AT THE OUTPUT WINDOW AREA; THE METAL CAP ADHESION LOCATION EXHIBITS BURNT GLUE; THERE ARE SIGNS OF BURN AT THE PROXIMAL / UV GLUE ZONE OF THE GLASS CAP. 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 362,477 JOULES WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER TIP WAS DAMAGES AND OBSERVED TO BE FORWARD-FIRING. TIME EXPENDED: 47 MINUTES. THE FIBER WAS REPLACED AND THE PROCEDURE COMPLETED USING A SECOND SURGICAL FIBER. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694967 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 424A

    Patients

    Seq Age Sex Outcome Treatment
    1