BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERAIII BRONCHOVIDEOSCOPE

    MDR report key: 8173149 · Received December 18, 2018

    Report

    Report Number
    8010047-2018-02453
    Event Type
    Death
    Date Received
    December 18, 2018
    Date of Event
    November 16, 2018
    Report Date
    June 17, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K121959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATES. THE DETAIL OF THE CONCOMITANT DEVICES WERE AS FOLLOWS. TRACHEAL TUBE (BRONCHOFLEX, RÜSCH ARTICLE 104103-000085). HIGH FREQUENCY GENERATOR (ERBE VIO 200 D PLUS) . ARGON BEAMER PROBE (ABP 20132-183). OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND OBTAINED ADDITIONAL INFORMATION AS FOLLOWS. THE USER FACILITY COMMENTED THAT THE CAUSE OF THE FIRE WAS DUE TO UNRECOGNIZED SHIFT IN RELATIVE DISTANCE BETWEEN THE TRACHEAL TUBE AND THE TIP OF THE ARGON BEAMER PROBE (ABP) IN OXYGEN ATMOSPHERE. THERE WAS NO IRREGULARITY FOUND ON THE SUBJECT DEVICE BEFORE THE PROCEDURE. ERBE'S NEUTRAL ELECTRODE (PATIENT PLATE) WAS INSTALLED CORRECTLY DURING THE PROCEDURE. THE USER FACILITY PRESUMED THAT THE CAUSE OF THE DEATH WAS DISCONTINUATION ACCORDING TO THE PATIENT WILL OF THERAPY FOR ADVANCED TUMOR DISEASE WITH POOR PROGNOSIS.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT. THE DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. DURING THE EVALUATION, IT WAS CONFIRMED THAT MOST OF THE BENDING SECTION AND THE DISTAL END WERE BURNT. CONSIDERING THE EVALUATION RESULTS ABOVE AND THE USER FACILITY'S STATEMENT THAT THEY WERE USING THE SUBJECT DEVICE WITH ARGON BEAM, SPECIAL TUBE, AND OXYGEN, THE REPORTED EVENT WAS LIKELY DUE TO ACTIVATING THE ARGON BEAM FEEDING OXYGEN OR WITH THE BRONCHUS FILLED WITH OXYGEN. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THE INSTRUCTION MANUAL OF THE DEVICE PROVIDES WARNINGS AS FOLLOWS; THE ARGON GAS ITSELF IS NEITHER COMBUSTIBLE NOR A PROMOTER OF COMBUSTIBLE SUBSTANCES, BUT THE ARGON PLASMA IS VERY HOT AND COULD IGNITE COMBUSTIBLE SUBSTANCES. FLAMMABLE SUBSTANCES BURN EASILY WHEN ARGON IS IRRADIATED IN THE PRESENCE OF COMBUSTIBLE GAS SUCH AS HIGH-CONCENTRATION OR PURE OXYGEN. BE SURE TO OBSERVE THE FOLLOWING CAUTIONS. - BEFORE AND DURING APC, DO NOT FEED OXYGEN OR OTHER COMBUSTIBLE GASES AND LIQUIDS INTO THE TRACHEOBRONCHIAL SYSTEM. - IF IT IS REQUIRED TO ACTIVATE APC FOR A FEW SECONDS, CHANGE BETWEEN APC AND OXYGEN FEEDING. - KEEP THE DISTAL END OF THE APC PROBE IN THE ENDOSCOPIC IMAGE BEFORE AND DURING ACTIVATION. NEVER ACTIVATE APC IN A POSITION YOU CANNOT OBSERVE.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THE SUBJECT DEVICE CAUGHT FIRE DURING A THERAPEUTIC BRONCHOSCOPIC PROCEDURE USING THE SUBJECT DEVICE AND AN ARGON BEAM COAGULATION WITH OXYGEN AND UNSPECIFIED SPECIAL TUBE. THE PATIENT WAS INJURED DURING THE PROCEDURE ON (B)(6) 2018. OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND OBTAINED ADDITIONAL INFORMATION ON (B)(6) 2018, THEY INFORMED THAT THE PATIENT WAS A (B)(6) YEAR-OLD WOMAN WITH A LUNG CARCINOMA AND HER LIFE EXPECTANCY WAS ABOUT 6 TO 12 MONTHS. SHE HAD BEEN IN INTENSIVE CARE AND HER CONDITION WAS STABLE AFTER THE PROCEDURE. OLYMPUS REPRESENTATIVE VISITED THE USER FACILITY AND OBTAINED AN ADDITIONAL INFORMATION THAT THE PATIENT HAD DIED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012810 EVIS EXERAIII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TH190

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death