BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 3050225 · Received April 5, 2013

    Report

    Report Number
    2937094-2013-00371
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    July 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODES: THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULT CODES THERMAL PROBLEM. REFERENCE MFRS# 2937094-2013-00369, 2937094-2013-00370 AND 2937094-2013-00372.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE FIBERS WERE USED IN A PROCEDURE. THE FIRST FIBER TIP BROKE OFF AT 173.000 JOULES. THE SECOND FIBER'S LASER BEAM WENT STRAIGHT AFTER 70.000 JOULES. THE THIRD FIBER TIP MELTED AT 212.000 JOULES. THE FOURTH FIBER'S LASER BEAM WENT STRAIGHT AFTER 50.000 JOULES. THE FIFTH FIBER TIP BROKE OFF AT +-100.000 JOULES. UNK HOW CASE WAS COMPLETED. THERE WAS "NO INJURY TO PT". THIS REPORT IS FO THE THIRD FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139770 GREENLIGHT HPS LASER SYSTEM SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS 0010-2090 941K

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT XPS SURGICAL LASER SYSTEM & ACCESSORIES