BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3940347 · Received July 17, 2014

    Report

    Report Number
    2937094-2014-00633
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERS TO FORWARD FIRING OF THE SIDE FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 GLASS CAP EXHIBITS MILD DEVITRIFICATION AND MILD DETRITUS ADHESION AT THE OUTPUT WINDOW; THE OUTER FLOW TUBING SHOW SIGNS OF MELTING AT THE OPEN END. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST FIBER WAS FORWARD FIRING AT 40,125 JOULES. THE SECOND FIBER WAS REPORTED TO HAVE A FIBER TIP DETACH AT 13,371 JOULES AND THE THIRD FIBER WAS FORWARD FIRING AT 14,245 JOULES. THE PROCEDURE WAS COMPLETED WITH A FOURTH FIBER AT 55,258 JOULES. PATIENT OUTCOME ¿OK.¿ THIS REPORT IS FOR THE FIRST FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419775 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 401A

    Patients

    Seq Age Sex Outcome Treatment
    1