BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT PV BPH FIBER OPTIC

    MDR report key: 3951965 · Received July 23, 2014

    Report

    Report Number
    2937094-2014-00652
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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 MODERATE CHAR; THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT THE OPEN END; THE HEAT SHRINK TUBE IS MELTED AT THE OPEN END; THE CONNECTOR INPUT FACE SHOWS EVIDENCE OF SOME BROWN SUBSTANCE (LIKELY BIOLOGIC) ON THE OPTICAL SURFACE. 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 CAP 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, THE DEVICE COUPLER OVERHEATED. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. NO PATIENT INJURY WAS REPORTED. GLAND VOLUME: 38 ML. JOULES USED: 7,790.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431890 GREENLIGHT PV BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2079 223U

    Patients

    Seq Age Sex Outcome Treatment
    1