BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 4581430 · Received March 9, 2015

    Report

    Report Number
    2937094-2015-00271
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Date of Event
    November 27, 2014
    Report Date
    February 3, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER IS PARTIALLY FRACTURED DISTAL TO UV GLUE ZONE AT THE BEVEL SECTION; THE GLASS CAP IS FRACTURED AT THE UV GLUE ZONE; THE FIBER/GLASS CAP DISTAL PART IS DETACHED AND NOT RETURNED; THE PROXIMAL PART OF THE FIBERGLASS CAP AT THE UV GLUE ZONE IS BLACKENED; THE DISTAL END OF THE SHRINK TUBING IS MELTED. 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 DURING A PROCEDURE, AT 80W; 232833 JOULES; 68 MINUTES, THE FIBER TIP OF THE FIBER WAS NOTED TO BE DAMAGED. THE FIBER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. NO INJURY TO THE PATIENT REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161612 AMS GREENLIGHT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2093 343J

    Patients

    Seq Age Sex Outcome Treatment
    1