BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3840669 · Received May 30, 2014

    Report

    Report Number
    2937094-2014-00419
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 5, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER CAP REMAINS INTACT AND ATTACHED AND EXHIBITS A DRILLED THROUGH CONDITION; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION; THE GLASS CAP EXHIBITS MILD DETRITUS ADHESION; THERE IS SOME WHITE UNKNOWN SUBSTANCE NOTED INSIDE THE FIBER CAP TIP; THE BEVEL SECTION IS SEVERELY MELTED. BASED ON THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, TIP DAMAGE, DECREASED TISSUE VAPORIZATION EFFICIENCY AND FORWARD-FIRING WERE OBSERVED. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. OUTCOME: "OK". NO PATIENT INJURY WAS REPORTED. GLAND VOLUME: 45 ML. JOULES USED: 166,560.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319050 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 322H

    Patients

    Seq Age Sex Outcome Treatment
    1