BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3802640 · Received May 9, 2014

    Report

    Report Number
    2937094-2014-00356
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 METAL CAP EXHIBITS MILD DETRITUS ADHESION; THE GLASS CAP EXHIBITS MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW. 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 LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, @ 30396 JOULES OF USE, THE FIBER EXHIBITED THE AIMING BEAM AND VAPORIZATION STRAIGHT OUT OF THE FIBER. THE SECOND FIBER, @ 33582 JOULES OF USE, EXHIBITED SIGNIFICANTLY DIMINISHED VAPORIZATION. THE THIRD FIBER, @ 102375 JOULES OF USE, EXHIBITED THE AIMING BEAM FIRES STRAIGHT OUT OF THE FIBER. THE FOURTH FIBER, @ 34168 JOULES OF USE, EXHIBITED SIGNIFICANTLY DIMINISHED VAPORIZATION EFFICIENCY. THE PROCEDURE WAS COMPLETED WITH THE USE OF A FIFTH FIBER @ 8893 JOULES OF USE. ¿NO PATIENT INJURY¿ REPORTED. THIS REPORT IS FOR THE FOURTH FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281873 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 349A

    Patients

    Seq Age Sex Outcome Treatment
    1