BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1833401 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00414
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 6, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER FAILED AFTER THE PHYSICIAN ATTEMPTED TO PUT THE FIBER INTO A NEW PORT SEAL THAT WAS TOO TIGHT AT 76,301 JOULES. NO INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER-SILICON VALLEY NA 023A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other