BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 4112881 · Received September 24, 2014

    Report

    Report Number
    2937094-2014-00869
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    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 CAP REMAINS INTACT AND ATTACHED AND EXHIBITS A DRILLED THROUGH CONDITION; THE BEVEL SECTION IS MELTED; THERE IS SOME WHITE UNKNOWN SUBSTANCE NOTED INSIDE THE FIBER CAP; THE FIBER WITHIN THE CAP EXHIBITS SEVERE CONTAMINATION, LIKELY BIOLOGIC; THE FIBER CAP EXHIBITS MILD DETRITUS ADHESION; THE HEAT SHRINK TUBE EXHIBITS MELTING AT THE OPEN END. BASED ON THE DEVICE ANALYSIS, 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 COMMENCED "FORWARD FIRING" AT 81,454 JOULES AND 18:44 MINUTES OF USAGE. CASE WAS COMPLETE WITH AN ALTERNATIVE PROCEDURE (TURP). PATIENT OUTCOME: "FINE" REPORTED, NO INJURIES TO PATIENT OR STAFF REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596058 AMS GREENLIGHT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2093 337J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other