BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2896643 · Received December 28, 2012

    Report

    Report Number
    2937094-2012-01362
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER. FIBER ANALYSIS: THE FIBER CAP REGION BURNT AND MELTED. THE FIBER CAP REMAINS INTACT AND EXHIBITS A DRILLED THROUGH CONDITION. THE FIBER CAP EXHIBITS DETRITUS, CHAR, DEVITRIFICATION AND MELTED GLASS. THE FIBER CAP CONDITION WOULD RESULT IN DECREASED VAPORIZATION EFFICIENCY. THE POTENTIAL FOR FORWARD FIRING EXISTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE SIDE-FIRING FIBER FLASHED, THEN LOT VAPORIZATION EFFICIENCY AT 38,431 JOULES. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PATIENT OR END USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 207H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYSTEM AND ACCESSORIES