BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4971542 · Received August 5, 2015

    Report

    Report Number
    2937094-2015-00792
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER/GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE AT DISTAL SIDE OF FIBER/CAP FUSION ZONE AT THE BEVEL EDGE; THE GLASS CAP EXHIBITS MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP EXHIBITS MODERATE CHARRED DETRITUS ADHESION; THE GLASS CAP IS PROTRUDING FROM THE METAL CAP; THIS IS INDICATIVE OF MELTING OF GLUE AT THE METAL TO GLASS CAP ADHESION LOCATION; THE OUTER FLOW TUBING EXHIBITS MILD CONTAMINATION. BASED ON DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE DEVICE ANALYSIS, 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 BPH SURGICAL PROCEDURE, ¿FIBER BROKEN" AT 21,681 JOULES AND 42:00 MINUTES OF USAGE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. PATIENT OUTCOME: "NO INJURIES" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511660 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 433A

    Patients

    Seq Age Sex Outcome Treatment
    1