BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3832137 · Received May 27, 2014

    Report

    Report Number
    2937094-2014-00408
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 21, 2014
    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

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER/GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/GLASS CAP FUSION ZONE AT THE BEVEL EDGE; THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP; THE METAL CAP EXHIBITS MODERATE CHAR; THE GLASS CAP EXHIBITS MODERATE DEVITRIFICATION AT THE OUTPUT WINDOW; THE DISTAL END OF THE FIBER/GLASS CAP IS DETACHED AND NOT RETURNED. 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 WHILE USING THE SURGICAL FIBER THE "FIBER BROKE - CAUSE UNKNOWN" @ 18 MINUTES AND 02 SECONDS AND 150,979 JOULES OF USE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. PATIENT OUTCOME: "NO DAMAGES TO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311030 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2400 343A

    Patients

    Seq Age Sex Outcome Treatment
    1