BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3871231 · Received June 13, 2014

    Report

    Report Number
    2937094-2014-00497
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    December 17, 2013
    Report Date
    May 20, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP IS DETACHED; THE GLASS CAP IS FRACTURED PROXIMAL TO GLUE ZONE; THE GLASS CAP IS RETURNED; THE GLASS CAP EXHIBITS A DRILLED THROUGH CONDITION; THE GLASS CAP EXHIBITS MODERATE DETRITUS ADHESION; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION; THERE IS SOME WHITE UNKNOWN SUBSTANCE NOTED INSIDE THE FIBER CAP TIP; THE BEVEL SECTION IS MELTED; THE FIBER IS BLACKENED; THE HEAT SHRINK TUBE 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 AT 50,000 JOULES WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER WAS OBSERVED TO BE FORWARD FIRING. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER, WHICH WAS ALSO REPORTED TO HAVE FAILED AT THE END OF THE PROCEDURE. OUTCOME: "NO ADVERSE OUTCOME FOR PATIENT". THIS REPORT IS FOR THE SECOND/FINISHING FIBER. GLAND VOLUME: 60 ML. JOULES USED: 87,733.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350353 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 303H

    Patients

    Seq Age Sex Outcome Treatment
    1