BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOSTAT

    MDR report key: 4946952 · Received July 28, 2015

    Report

    Report Number
    2937094-2015-00770
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    June 10, 2015
    Report Date
    July 7, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . ADDITIONAL INFORMATION: A FLEXIBLE FIBEROPTIC BRONCHOSCOPE (ATTACHED TO A CAMERA) AND A 0.6 BARE ENDOSTAT FIBER ((B)(4)) WERE USED DURING THIS PROCEDURE. THE POWER SETTINGS OF THE LASER, % OF OXYGEN USED OR TYPE OF ET TUBE WAS NOT REPORTED TO AMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE YAG LASER DURING A PROCEDURE TO "ABLATE AN UPPER LOBE ENDO-BRONCHIAL TUMOR, AN AIRWAY FIRE OCCURRED". REPORTEDLY, DURING THE PROCEDURE,"THE SCREEN WENT BLACK AND THE PHYSICIAN SAW A "FLASH". THE PHYSICIAN IMMEDIATELY TURNED OFF THE O2, REMOVED THE ET TUBE AND PUT ICE INTO THE PATIENT. THE PATIENT WAS THEN INTUBATED AND UPON BRONCHOSCOPY, AN "INJURY IN THE AIRWAY WAS NOTED". THE PATIENT WAS IMMEDIATELY TRANSFERRED TO A BURN UNIT AT ANOTHER HOSPITAL. DETAILS OF THE TREATMENT RECEIVED AT THE BURN UNIT WAS NOT AVAILABLE. THERE WAS NO FURTHER INFORMATION REPORTED TO THE HOSPITAL; THEY RECEIVED A CALL ON JUNE 19, 2015 THAT THE PATIENT EXPIRED. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488616 ENDOSTAT POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0612

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| H| R