BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3880869 · Received June 18, 2014

    Report

    Report Number
    2937094-2014-00513
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 3, 2014
    Report Date
    May 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP IS PARTIALLY FRACTURED DISTAL TO GLUE ZONE; THE FIBER IS FRACTURED AT THE BEVEL EDGE; THE DISTAL END OF THE GLASS CAP IS 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE THE FIBER WAS NOTED TO HAVE "TIP DAMAGE, BEAM COME OUT AT THE END" THE PROCEDURE WAS COMPLETED WITH THE USE OF A SECOND FIBER. PATIENT OUTCOME WAS REPORTED AS ¿OK¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357726 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 318H

    Patients

    Seq Age Sex Outcome Treatment
    1