BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERAII BRONCHOVIDEOSCOPE

    MDR report key: 6077933 · Received November 3, 2016

    Report

    Report Number
    2951238-2016-00825
    Event Type
    Death
    Date Received
    November 3, 2016
    Report Date
    September 29, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    PMA / PMN Number
    PK061313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE USER FACILITY AND OLYMPUS IS ARRANGING A DATE TO VISIT THE SITE TO OBSERVE AN UNIDENTIFIED ORGANIZATION GATHER CULTURES FROM THE BRONCHOSCOPE AS PART OF THEIR INVESTIGATION OF THE REPORTED EVENTS. IN ADDITION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY ON OCTOBER 19, 2016 TO ASSESS THEIR REPROCESSING PRACTICES AND PROVIDED REPROCESSING TRAINING. THE ESS FOUND THE FOLLOWING REPROCESSING DEVIATIONS: THE USER FACILITY WAS NOT SUCTIONING THE SCOPE AFTER MANUAL BRUSHING. INSTEAD, THE USER FACILITY WAS USING A NON OLYMPUS ENDOSCOPE FLUSHING AID (SCOPE BUDDY MANUFACTURED BY (B)(4)) TO FLUSH THE CHANNELS OF THE SCOPE. THE CAUSE OF THE REPORTED POSITIVE CULTURE COULD NOT BE DETERMINED BUT IMPROPER MAINTENANCE OF THE DEVICE CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR. CHAPTER 3 OF THE REPROCESSING INSTRUCTION MANUAL STATES, ¿TURN THE SUCTION PUMP ON. WHEN USING THE BIOPSY VALVE (MD-495), ATTACH THE BIOPSY VALVE¿S CAP. IMMERSE THE DISTAL END OF THE INSERTION SECTION IN DETERGENT SOLUTION. DEPRESS THE SUCTION VALVE AND ASPIRATE DETERGENT SOLUTION INTO THE INSTRUMENT CHANNEL FOR 30 SECONDS."

    Additional Manufacturer Narrative · 1

    THE USER FACILITY FURTHER REPORTED ON (B)(6) 2017 THAT THEY HAVE NO PLANS IN RETURNING THE SCOPE TO OLYMPUS FOR EVALUATION. IN ADDITION, THE USER FACILITY REPORTED THAT THE FREQUENCY OF USE FOR THE SCOPE IS APPROXIMATELY 10 TIMES A MONTH FROM (B)(6) THROUGH MID (B)(6) 2016. IT WAS ALSO REPORTED THAT A NON OLYMPUS ACCESSORY (COVIDIEN (B)(4)) WAS ATTACHED TO THE BIOPSY PORT. A NON OLYMPUS MEDIVATOR DSD AUTOMATED ENDOSCOPE REPROCESSOR (AER) MACHINE ALONGSIDE MEDIVATOR SCOPE BUDDY CONNECTOR IS USED TO REPROCESS THE SCOPE. THE SCOPE IS HUNG IN A VENTILATED CABINET TO DRY. IT WAS ALSO REPORTED THAT THE (B)(4) PATIENTS THAT TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA UNDERWENT BRONCHOSCOPY PROCEDURES IN (B)(6) AND (B)(6) OF 2016. THE DATE THAT THE INFECTIONS WERE CONFIRMED WAS ON (B)(6) 2016. IN ADDITION, THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) PERFORMED A REPRODUCTION TEST ON A BF-1T180 SCOPE WITH A SIMILAR NON OLYMPUS MEDTRONIC EDGE ADAPTER BORROWED FROM THE USER FACILITY. IT WAS FOUND THAT THE INSTRUMENT CHANNEL PORT OF THE BF-1T180 SCOPE DID NOT COME LOOSE.

    Additional Manufacturer Narrative · 1

    OMSC CONDUCTED A ROOT CAUSE ANALYSIS OF THIS REPORT AND OTHER SIMILAR COMPLAINTS RELATED TO LOOSE BIOPSY PORTS. THE ROOT CAUSE ANALYSIS INCLUDED UTILIZING AN OLYMPUS ADAPTOR AND NON-OLYMPUS ADAPTORS (COVIDIEN AND MEDIVATOR) IN AN ATTEMPT TO IDENTIFY THE POSSIBLE CAUSES OR CONTRIBUTORY FACTORS THAT COULD LEAD TO ¿LOOSE BIOPSY PORT¿ ON BRONCHOSCOPES. BASED ON OMSC¿S ANALYSIS IT WAS DETERMINED THAT THE BIOPSY PORT (K-PORT) WILL NOT BECOME LOOSE DURING NORMAL USE. OMSC FOUND THAT USING A COVIDIEN ADAPTOR POSSIBLY LEADS TO GREATER TORQUE FORCES THAN THE CURRENT MANUFACTURING SPECIFICATION FOR THE BIOPSY PORT, RESULTING IN LOOSENING OF THE BIOPSY PORT. OLYMPUS DOES NOT SUPPORT OR RECOMMEND THE USE OF A NON-OLYMPUS BIOPSY PORT ADAPTOR. THE INSTRUCTIONS FOR USE (IFU) INSTRUCT THE USER TO INSPECT THE ENDOSCOPE PRIOR TO USE, AND INSPECT THE CONTROL SECTION AND THE ENDOSCOPE CONNECTOR FOR EXCESSIVE SCRATCHING, DEFORMATION, LOOSE PARTS, OR OTHER IRREGULARITIES. IN THE EVENT THAT SUCH IRREGULARITIES ARE OBSERVED, THE IFU INSTRUCT USER TO STOP USE OF THE DEVICE AND CONTACT OLYMPUS. THE IFU PROVIDES LIST OF COMPATIBLE ENDOTHERAPY AND ACCESSORIES TO BE USED WITH THE BRONCHOSCOPE. THE IFU STATES THAT USING AN INCOMPATIBLE ACCESSORIES OR EQUIPMENT CAN RESULT TO PATIENT OR OPERATOR INJURY AND/OR EQUIPMENT DAMAGE. IN AN EFFORT TO PREVENT BIOPSY PORT LOOSENESS, OMSC PLANS ON CREATING AN EVEN MORE ROBUST TIGHTENING FORCE SPECIFICATION FOR THE BIOPSY PORT TO BE RESISTANT TO ABNORMALLY HIGH APPLIED FORCES. THE CHANGE IN SPECIFICATION AFFECTS ¿RESPIRATORY ENDOSCOPES.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT 13 PATIENTS TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA AFTER UNDERGOING AN UNSPECIFIED PROCEDURE USING AN OLYMPUS BRONCHOVIDEOSCOPE. 2 OUT OF THE 13 PATIENTS WERE IDENTIFIED AS HAVING COMORBIDITY MEDICAL CONDITIONS AND HAVE SINCE EXPIRED. THE DATES OF THE TWO DEATHS ARE UNKNOWN. IT WAS ALSO REPORTED THAT MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENTS; HOWEVER, NO DETAILS WERE PROVIDED. IN ADDITION, THE BRONCHOVIDEOSCOPE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA AFTER REPROCESSING. THERE WAS BIOMATTER FOUND UNDERNEATH THE O-RING OF THE SCOPE. THE SCOPE WAS REMOVED FROM SERVICE ON SEPTEMBER 16, 2016. THIS IS 2 OF 13 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727109 EVIS EXERAII BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T180 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R