BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 4092528 · Received September 16, 2014

    Report

    Report Number
    2937094-2014-00836
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 11, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER 0010-2400-416A-(B)(4). THE FIBER SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE DISTAL TO THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITS MODERATE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE METAL CAP ADHESION LOCATION EXHIBITS BURNT GLUE; THE OUTER FLOW TUBING EXHIBITS MILD CONTAMINATION, LIKELY BIOLOGIC. 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 WOULD LIMIT THE PERFORMANCE OF THE FIBER. (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, "FIBER START GOING ON AND OFF OVER AND OVER DURING THE PROCEDURE UNTIL THE SYSTEM REQUEST A NEW FIBER", AT 89,934 JOULES AND 13:23 MINUTES OF USAGE.THE FIBER WAS EXCHANGED AND THE CASE COMPLETED. PATIENT OUTCOME: ¿OK¿ REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573056 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 416A

    Patients

    Seq Age Sex Outcome Treatment
    1