BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT XPS

    MDR report key: 2481364 · Received March 5, 2012

    Report

    Report Number
    2937094-2012-00239
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE APPEARED TO BE A MID-FIBER BREAKS AND THAT LASER ENERGY WAS EMITTED FROM THE BREAK DURING PROSTATE VAPORIZATION. NO PT OR END USER INJURY WAS REPORTED. THE JOULE COUNT ON THE FIBER WHEN THE PROBLEM WAS NOTED WAS NOT REPORTED. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT XPS SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2400 149A

    Patients

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