BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCUFLEX

    MDR report key: 1516033 · Received October 23, 2009

    Report

    Report Number
    2030430-2009-00003
    Event Type
    Death
    Date Received
    October 23, 2009
    Date of Event
    December 29, 2006
    Report Date
    October 14, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - PHOENIX
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT FROM USER WAS NOT REPORTED TO AMS OR OUR DISTRIBUTOR FOR THIS DEVICE. DEVICE HAS NOT BEEN RETURNED FOR EVAL, AND AMS HAS NOT BEEN ABLE TO CONFIRM THE FIBER USED IS OUR ACCUFLEX DEVICE. DISTRIBUTOR BELIEVES IT MUST BE THIS DEVICE, AS THEY BELIEVE IT IS THE ONLY ONE THEY SELL THAT IS COMPATIBLE WITH THE MODEL OF LASER USED IN THE PROCEDURE.

    Description of Event or Problem · 1

    DISTRIBUTOR FORWARDED NOTICE OF A LEGAL COMPLAINT FILED AGAINST THEM INVOLVING AN ACCUFLEX FIBER. THE DISTRIBUTOR'S INTERNAL INVESTIGATION LEADS THEM TO BELIEVE THAT THIS WAS A PROCEDURE IN WHICH A 1000UM ACCUFLEX FIBER WAS USED WITH A LASER TO REMOVE MUCUS FROM LUNG TRANSPLANT PATIENTS. DURING THE PROCEDURE, THE LASER FIRED INTO THE BRONCHOSCOPE, CAUSING THE BRONCHOSCOPE TO BURN AND THE PT TO HAVE A MILD THERMAL BURNS ALONG THE TRACK OF THE BRONCHOSCOPE. THE COMPLAINT FURTHER ALLEGES THAT THIS EVENT PLAYED A ROLE IN THE PT'S DEATH 4 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFLEX LASER FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - PHOENIX UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O