BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 5113796 · Received September 30, 2015

    Report

    Report Number
    2937094-2015-00973
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 15, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 DETRITUS ADHESION. 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 DURING A BPH SURGICAL PROCEDURE; "FORWARD FIRING" WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. PATIENT OUTCOME "GOOD" REPORTED. NO INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645690 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 504A

    Patients

    Seq Age Sex Outcome Treatment
    1