BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 16961168 · Received May 19, 2023

    Report

    Report Number
    9610595-2023-07700
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    March 17, 2021
    Report Date
    August 2, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170335181
    PMA / PMN Number
    K121959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENTS WERE DISCOVERED WITH THE CULTURE RESULTS AS IDENTIFIED FOR THE PATIENT LISTED IN B5. THE USER FACILITY PROVIDED ADDITIONAL INFORMATION REGARDING THE CLEANING, THE DISINFECTION AND THE STERILIZATION PROCESSES PERFORMED ONSITE FOR THE ENDOSCOPES. ACCORDINGLY, TO THE CUSTOMER THE SCOPE WAS REPROCESSED AFTER EVERY USE WITH NO DELAY, AND WATER WAS ASPIRATED THROUGH THE INSTRUMENT/SUCTION CHANNEL WITH A SUCTION PUMP. NO ABNORMALITIES WERE FOUND WITH THE REPROCESSING ACCESSORIES AND THE SCOPE PASSED LEAK TESTING. MANUAL CLEANING WAS ALSO PERFORMED 1 HR. AFTER THE PROCEDURE AND THE SCOPE INSTRUMENT/SUCTION/BALLOON CHANNEL, AIR/WATER/SUCTION/BIOPSY VALVE WERE BRUSHED, AND PURE (BOSTON SCIENTIFIC) DETERGENT SOLUTION WAS USED. FOR AUTOMATED ENDOSCOPE REPROCESSOR (AER) TREATMENT, THE MEDIVATORS REPROCESSOR ALONG WITH INTERCEPT PLUS DETERGENT AND RAPACIDE PA DISINFECTANT WERE USED. THE REPROCESSOR AND THE SCOPE WERE NOT TESTED. AS PART OF THEIR OWN INVESTIGATION, THE FACILITY INVITED STATE SURVEYORS TO COME AND INVESTIGATE THEIR PROCESSES WHICH DID NOT TURN UP ANY DEFINITIVE CONCLUSIONS AS TO THE CAUSE OF THESE POSITIVE CULTURES. THE CUSTOMER DECIDED TO SEND ONE SCOPE TO OLYMPUS (B)(6) BF-Q190 / 2600888). DEPENDING ON FINDINGS, THE FACILITY WILL DISCUSS AND DECIDE ON THE NEED TO SEND THE ADDITIONAL SCOPES IN FOR INVESTIGATION. THE SCOPE WAS SENT TO NELSON LAB BY OLYMPUS FOR INDEPENDENT CULTURE TESTING. THE CUSTOMER REPORTED THAT THE LAST REPROCESSING IN-SERVICE CONDUCTED BY AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST WAS (B)(6) 2022. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISIT WAS SCHEDULED FOR A FUTURE DATE TO OBSERVE THE USER FACILITY¿S REPROCESSING PRACTICES FROM START TO FINISH AND PROVIDE REPROCESSING IN-SERVICE TRAINING. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304 -2023-00129.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER. NEW INFORMATION ADDED TO THE FOLLOWING FIELD: B5.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, OBVIOUS DEVIATION FROM THE INSTRUCTION MANUAL REGARDING DEVICE REPROCESSING WAS NOT OBSERVED (PER THE INFORMATION PROVIDED BY THE FACILITY). SINCE THE SUBJECT DEVICE WAS NOT RETURNED FOR AN EVALUATION, A CULTURE TEST WAS NOT PERFORMED BY OLYMPUS. THEREFORE, THE REPORTED ISSUE COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATES: ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA BRONCHOVIDEOSCOPE BRONCH WASH TESTED POSITIVE FOR SAROCLADIUM DURING A ROUTINE CULTURE OF THE SCOPE. THE SAMPLING WAS TAKEN AT REPROCESSING, BEFORE USE. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE 16 PATIENTS WITH POSITIVE CULTURE RESULTS BETWEEN (B)(6) 2018 AND (B)(6) 2022. NONE OF THE PATIENTS WERE TREATED FOR THIS ORGANISM. THE FOLLOWING MEDWATCH REPORTS ARE RELATED: COMPLAINT NUMBERS MODEL#/ SERIAL # PROCEDURE DATE PATIENT 1 - (B)(6) BF-Q190 / 2600888 (B)(6) 2019 PATIENT 1 - (B)(6) BF-UC180F / 7621241 (B)(6) 2019 PATIENT 2 - (B)(6) BF-Q190 / 2600888 (B)(6) 2020 PATIENT 2 - (B)(6) BF-UC180F / 7621241 (B)(6) 2020 PATIENT 3 - (B)(6) BF-1T180 / 2043525 ADMIT: (B)(6) 2020, BRONCH: (B)(6) 2020 PATIENT 4 - (B)(6) BF-Q190 / 2600888 (B)(6) 2020 PATIENT 5 - (B)(6) BF-UC180F / 7621241 (B)(6) 2020 PATIENT 6 - (B)(6) BF-1TH190 / 2602459 (B)(6) 2020 PATIENT 6 - (B)(6) BF-UC180F / 1312053 (B)(6) 2020 PATIENT 7 - (B)(6) BF-UC180F / 1312053 (B)(6) 2020 PATIENT 8 - (B)(6) BF-1TH190 / 2602459 (B)(6) 2020 PATIENT 8 - (B)(6) BF-UC180F / 1312053 (B)(6) 2020 PATIENT 9 - (B)(6) BF-Q190 / 2600888 (B)(6) 2020 PATIENT 10 - (B)(6) BF-1TH190 / 2602459 (B)(6) 2021 PATIENT 10 - (B)(6) BF-UC180F / 7621241 (B)(6) 2021 PATIENT 11 - (B)(6) BF-Q190 / 2600888 (B)(6) 2021 PATIENT 12- (B)(6) BF-1TH190 / 2602459 (B)(6) 2021 PATIENT 12 - (B)(6) BF-UC180F / 1312053 (B)(6) 2021 PATIENT 13 - (B)(6) BF-1T180 / 2043525 (B)(6) 2021 PATIENT 13 - (B)(6) BF-UC180F / 7621241 (B)(6) 2021 PATIENT 14 - (B)(6) BF-Q190 / 2600888 (B)(6) 2021 PATIENT 15 - (B)(6) BF-P190 / 2500487 (B)(6) 2021 PATIENT 16 - (B)(6) BF-Q190 / 2600888 (B)(6) 2022 THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) : INFECTION VERIFIED VIA BRONCHOALVEOLAR LAVAGE RLL, RESULTS (B)(6) 2021 SAROCLADIUM SPECIES. PATIENT'S CURRENT CONDITION ALIVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATING ALL THE REPORTED SCOPES WERE UTILIZED ON PATENTS WHO HAD POSITIVE CULTURES FOR SAROCLADIUM POST BRONCHOSCOPY PROCEDURE. THE FACILITY HAS NOT IDENTIFIED SAROCLADIUM IN THE SCOPES THEMSELVES. ALL OF THESE CASES WERE DETERMINED BY DR. (B)(6) TO NOT ACTUALLY BE INFECTED AS NO SIGNS OR SYMPTOMS CORRELATED WITH A FUNGAL INFECTION, NO TREATMENT OR MEDICAL INTERVENTION DONE. THERE WERE NO NOSOCOMIAL INFECTION CASES IN THE HOSPITAL, INVOLVING THE SAME MICROORGANISMS DETECTED IN THE REPORTED PATIENTS, DURING THE PERIOD BETWEEN 2019 AND 2022. THERE NO EVIDENCE FOUND OF CONTAMINATION OF BRONCHOALVEOLAR LAVAGES DURING COLLECTION AND/OR MICROBIOLOGICAL CULTURE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478835 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TH190 04953170335181

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other