BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 17936811 · Received October 14, 2023

    Report

    Report Number
    3002808148-2023-11291
    Event Type
    Injury
    Date Received
    October 14, 2023
    Date of Event
    September 12, 2023
    Report Date
    January 11, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE NOTE THAT THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS AND AN EVALUATION WAS PERFORMED, DOCUMENTED, AND REPORTED UNDER RELATED RECORD (PATIENT IDENTIFIER # (B)(6) ). ALTHOUGH D9 AND H3 HAVE BEEN MARKED AS "YES," AND H6 CODE "10" HAS BEEN SELECTED IN THIS REPORT, THE DEVICE EVALUATION RESULTS HAVE BEEN REPORTED (IN MEDWATCH # 210691) UNDER PATIENT IDENTIFIER # (B)(6) . A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN MORE THAN 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. CULTURE TESTING WAS PERFORMED BY A THIRD-PARTY INSTITUTION, AND THE RESULTS CONFIRMED THAT THERE WERE NO BACTERIA DETECTED. BASED ON THE RESULTS OF THE INVESTIGATION, A RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE RESULTS OF THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) CHECKLIST CONFIRMED THAT THERE WERE NO OBVIOUS DEVIATIONS IN THE REPROCESSING STEPS FROM THE INSTRUCTION FOR USE (IFU) MANUAL. THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE IFU IN SECTIONS: CHAPTER 6: COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS. CHAPTER 7: CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES. CHAPTER 8: CLEANING AND DISINFECTION EQUIPMENT. THIS SUPPLEMENTAL REPORT ALSO INCLUDES INFORMATION ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS ONGOING. THE USER FACILITY CONFIRMED THAT THE SAMPLES SENT FROM THE SCOPE CAME BACK NEGATIVE. THE USER FACILITY PROVIDED THEIR CLEANING, DISINFECTION, STERILIZATION PROCESS STATING THAT PRECLEANING WAS PERFORMED IMMEDIATELY AFTER PATIENT PROCEDURE. WATER WAS ASPIRATED THROUGH THE INSTRUMENT/SUCTION CHANNEL WITH A SUCTION PUMP AND THE AIR/WATER CHANNEL WAS FLUSHED WITH WATER AND AIR BY USING MH-948. REVITAL OX BESIDE SIDE COMPLETE 215MLS ENZYMATIC DETERGENT WAS USED IN PRE-CLEAN 'BEDSIDE CLEAN'. IF MANUAL CLEANING WAS NOT PERFORMED WITHIN 1 HOUR, PRE-SOAKING WAS PERFORMED. THE DEVICE PASSED THE LEAK TEST. THE DETERGENT USED FOR MANUAL CLEANING WAS SERCHEM NEUTRASCOPE-A.F. THE FOLLOWING INSTRUMENT / SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, AND BALLOON CHANNEL WERE BRUSHED. THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) USED IS GETTLINGE ED-FLOW WITH GETINGE DLC/POKA YOKE DLC DETERGENT AND GETINGE APERIAN POKA YOKE AGENT A AND B DISINFECTANT. ALL CHANNELS WERE CONNECTED WITH TUBES WHEN THE ENDOSCOPE WAS SETTING UP INTO THE AER. THE CONCENTRATION AND EXPIRATION OF THE DISINFECTANT WAS CONTROLLED. THE WATER QUALITY WAS FILTER WATER AND THE FILTER WAS REPLACED PERIODICALLY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. ONE SCOPE WAS USED STRAIGHT TO THE PATIENT AND DRIED WITH STERILE GAUZE WHILE OTHERS WERE PLACED IN A DRYING CABINET. THE DEVICE WAS STORED IN A DRYING CABINET. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE WAS USED ON A PATIENT (PATIENT 1) WHO WAS SUBSEQUENTLY FOUND TO BE POSITIVE FOR KLEBSIELLA OXYTOCA INFECTION (THROUGH SAMPLES OF FLUSHED FLUID FROM THE PATIENT). THE SCOPE WAS REPROCESSED AS USUAL AND USED ON A SECOND PATIENT (PATIENT 2) THE FOLLOWING DAY. PATIENT 2 WAS ALSO FOUND TO BE POSITIVE FOR KLEBSIELLA OXYTOCA INFECTION. THE SCOPE WAS USED ON A THIRD PATIENT (PATIENT 3) SEVEN DAYS AFTER PATIENT 2 WHO THEN BECAME POSITIVE FOR STREPTOCOCCUS. THE PATIENT DID NOT HAVE KLEBSIELLA OXYTOCA. THE FOLLOWING DAY, THE SCOPE WAS THEN USED ON A FOURTH PATIENT (PATIENT 4), WHO WAS ALSO FOUND TO BE POSITIVE FOR KLEBSIELLA OXYTOCA INFECTION. THE STAFF THEN LIAISED WITH "IP" AND A MICROBIOLOGIST AND TOOK THE SCOPE OUT OF USE. THE CUSTOMER INDICATED THAT ALTHOUGH THE SCOPE WAS WORKING, THEY ARE CONCERNED THAT THERE WAS SOMETHING WITH THE SCOPE LEADING IT TO BE SUSCEPTIBLE TO HARBORING KLEBSIELLA OXYTOCA DESPITE REPROCESSING. THE CUSTOMER WAS ADVISED TO SEND THE SCOPE FOR REPAIR TO OLYMPUS AND THE INCIDENT WILL BE INVESTIGATED. THE CUSTOMER HAS ALSO REVIEWED PATIENTS ON WHOM THAT SCOPE WAS USED ON PRIOR TO PATIENT 1, AND NONE WERE POSITIVE FOR KLEBSIELLA OXYTOCA, SO IT WAS SURMISED THAT PATIENT 1 WAS THE INITIATOR OF THE KLEBSIELLA OXYTOCA CONTAMINATION OF THE SCOPE. ADDITIONAL INFORMATION WAS LATER RECEIVED FROM THE CUSTOMER. PATIENTS 1, 2, AND 4 ALL HAD AN ENDOBRONCHIAL ULTRASOUND (EBUS) TO CHECK FOR MALIGNANCY. THE PATIENTS DID NOT EXHIBIT ANY SYMPTOMS AND RECEIVED ANTIBIOTICS. NONE REQUIRED HOSPITAL ADMISSION. ONE OF THE 3 PATIENTS WITH KLEBSIELLA WAS BEING MANAGED BY ANOTHER FACILITY, AND THE OTHER 2 WERE PROGRESSING FROM A MALIGNANCY SYMPTOM POINT OF VIEW AND ARE UNDER PALLIATIVE CARE AND ONCOLOGY. PATIENT 3 UNDERWENT AN EBUS UNDER GENERAL ANESTHESIA AND WAS REFERRED BY ANOTHER FACILITY, THEREFORE THERE WAS NO FURTHER CLINICAL INFORMATION AVAILABLE. THIS PATIENT WAS REFERRED WITH A QUERY OF SARCOID AFTER AN INCIDENTAL FINDING OF ENLARGED LYMPH NODES ON IMAGING AS THEY HAVE SEVERE ASTHMA ON BIOLOGICS. THE REFERRER WAS INFORMED OF THE GROWTH AND SENSITIVITIES, SO IT WAS PRESUMED ANTIBIOTICS WERE SORTED LOCALLY. THE CUSTOMER ALSO REPORTED THAT THE SAMPLES THAT WERE SENT FROM THE SCOPE CAME BACK NEGATIVE SO IF NO FAULT WAS FOUND ON THE SCOPE AFTER SERVICE, THE CUSTOMER WOULD BE HAPPY TO PUT THE SCOPE BACK INTO CIRCULATION AFTER RISK ASSESSMENT. THERE WAS NO FURTHER PATIENT IMPACT REPORTED. THIS EVENT IS CAPTURED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - PATIENT 1. (B)(6) - PATIENT 2. (B)(6) - PATIENT 3. (B)(6) - PATIENT 4. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716340 EVIS LUCERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC260FW

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other