BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1843992 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00172
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 14, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS INNOVATION CENTER
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER TIP BROKE AT 18,000 JOULES. THE CASE WAS CONTINUED WITH TURP. NO PATIENT INJURY WAS REPORTED. THE FAILURE ANALYSIS REPORT IS PENDING FROM AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS INNOVATION CENTER NA 923U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other