BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 4922961 · Received July 17, 2015

    Report

    Report Number
    2951238-2015-00300
    Event Type
    Death
    Date Received
    July 17, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 18, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K112846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. A REVIEW OF THE INSTRUMENT HISTORY SHOWS THAT THE DEVICE WAS PURCHASED ON 10/25/2013 AND WAS LAST SERVICED ON 02/04/2015. THE EXACT CAUSE OF THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT #(B)(4) STATING "BRONCHOSCOPE IN USE WHEN AN AIRWAY FIRE OCCURRED DURING THE USE OF A YAG LASER TO ABLATE AN UPPER LOBE ENDO-BRONCHIAL TUMOR." OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND WAS INFORMED THAT THE EVENT OCCURRED DURING A LASER BRONCHOSCOPY WITH ABLATION OF A LEFT LUNG TUMOR PROCEDURE. A FIRE OCCURRED IN THE THROAT/ AIRWAY OF THE PATIENT WHILE USING THE DEVICE IN CONNECTION WITH AN AMS LASER AND AN AESTIVA ANESTHESIA MACHINE, THE FIRE MELTED THE TIP OF THE SCOPE ABOUT 5 INCHES FROM THE DISTAL TIP. THE PATIENT WAS HOSPITALIZED POST SURGERY FOR ONE DAY AND WAS THEN TRANSFERRED TO THE BURN UNIT. PATIENT EXPIRED AT THE BURN UNIT ON (B)(6) 2015. IT IS UNKNOWN AT THIS TIME WHAT LED TO THE PATIENT'S OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466183 EVIS EXERA III BRONCHOVIDEOSCOPE EVIS EXERA III BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORPORATION BF-1TH190 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death AESTIVA ANEATHESIA MACHINE MODEL AESTIVA| CLV-190 EVIS EXERA III VIDEO XENON LIGHT SOURCE| CV-190 EVIS EXERA III VIDEO SYSTEM| KTP/YAG LASER: LASERSCOPE MODEL 804| AESTIVA ANEATHESIA MACHINE MODEL AESTIVA| CLV-190 EVIS EXERA III VIDEO XENON LIGHT SOURCE| KTP/YAG LASER: LASERSCOPE MODEL 804| CV-190 EVIS EXERA III VIDEO SYSTEM