BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 3965024 · Received July 29, 2014

    Report

    Report Number
    2937094-2014-00665
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 8, 2014
    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

    FAILURE ANALYSIS FOR FIBER (B)(4):THE DISTAL PART OF THE GLASS CAP IS DETACHED AND NOT RETURNED; THE FIBER IS FRACTURED DISTAL TO GLUE ZONE AT THE BEVEL EDGE; THE FIBER EXHIBITS MODERATE DETRITUS ADHESION. 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 SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE BEAM WAS OBSERVED TO BE FORWARD-FIRING.THE PROCEDURE WAS COMPLETED UPON DEVICE MALFUNCTION.THE PATIENT OUTCOME WAS REPORTED TO BE "FINE" - THERE WERE NO INJURIES REPORTED.GLAND VOLUME: 70 ML.TIME EXPENDED: 30 MINUTES.JOULES USED: 100,000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441266 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