BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4092909 · Received September 16, 2014

    Report

    Report Number
    2937094-2014-00839
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 7, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    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 METAL CAP EXHIBITS MODERATE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE FIBER CAP ALSO EXHIBITS SIGNS OF A CIRCUMFERENTIAL FRACTURE OF GLASS CAP PROXIMAL TO FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THIS FAILURE MODE IS INDICATIVE OF A FRACTURE BENEATH THE METAL CAP; THE OUTER FLOW TUBING EXHIBITS MILD CONTAMINATION, LIKELY BIOLOGIC. BASED ON THE ANALYSIS RESULTS, 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 DURING A PROSTATE PROCEDURE @ 60800 JOULES; 10 MINUTES OF USE, ¿FIBER DEFECTED 180W¿ WAS NOTED. FIBER WAS EXCHANGED AND PROCEDURE COMPLETED WITH THE SECOND FIBER. "NO DAMAGE TO THE PATIENT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573547 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 415A

    Patients

    Seq Age Sex Outcome Treatment
    1