BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3874481 · Received June 16, 2014

    Report

    Report Number
    2937094-2014-00503
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 29, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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; THE HEAT SHRINK TUBE IS DAMAGED WITH SCRATCH MARKS AND MELTING AT THE OPEN END. 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 TWO SURGICAL FIBERS WERE USED DURING A PROSTATE PROCEDURE, AND BOTH FIBERS DID NOT VAPORIZE PROPERLY. THE CASE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP). THERE WAS NO PATIENT INJURY REPORTED. GLAND VOLUME: 80 ML. TIME EXPENDED: 15 MINUTES. JOULES USED: 50,800. THIS REPORT IS FOR THE SECOND SURGICAL FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352280 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 319H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other