BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3790704 · Received May 5, 2014

    Report

    Report Number
    2937094-2014-00343
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS DOES NOT SUPPORT THE REPORTED ISSUE OF FORWARD FIRING PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE METAL CAP EXHIBITS MODERATE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT OUTPUT WINDOW; THE METAL CAP IS LOOSE FROM THE GLASS CAP; THE BEVELED EDGE AT THE OUTPUT WINDOW IS OFF CENTER; THE GLASS CAP CAN ROTATE OFF CENTER; THE OUTER FLOW TUBING EXHIBITS SEVERE CONTAMINATION, LIKELY BIOLOGIC. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PRODUCT COMPLAINT OF " FORWARD FIRING" COULD NOT BE CONFIRMED; A GLUE FAILURE WAS FOUND; 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, ¿FORWARD FIRING AND/OR FIBER DAMAGED AT TIP OCCURRED INSIDE PT.¿ @ 67,270 JOULES,100 ML. TIME EXPENDED 12:04. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THERE WAS ¿NO PATIENT INJURY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267012 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