BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3983703 · Received August 6, 2014

    Report

    Report Number
    2937094-2014-00691
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 24, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DISTAL PART OF THE GLASS CAP IS DETACHED AND NOT RETURNED; THE FIBER IS FRACTURED DISTAL TO GLUE ZONE AT THE BEVEL EDGE; THE FIBER EXHIBITS CONTAMINATION, LIKELY BIOLOGIC, AT THE BREAK; THE HEAT SHRINK TUBE IS MELTED AT THE OPEN END; THE FIBER EXHIBITS MILD DETRITUS ADHESION. 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 TIP DAMAGE OCCURRED WHILE USING FOUR SURGICAL FIBERS DURING A PROSTATE PROCEDURE (AT 1,672 J, 2,447 J, 1,041 J, AND 4,157 JOULES OF USE RESPECTIVELY). THE PROCEDURE WAS COMPLETED USING A FIFTH SURGICAL FIBER. THERE WAS NO PATIENT INJURY REPORTED. THIS REPORT IS FOR THE FIRST SURGICAL FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461338 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 347H

    Patients

    Seq Age Sex Outcome Treatment
    1