BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

    MDR report key: 16853806 · Received May 2, 2023

    Report

    Report Number
    9610595-2023-06981
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 13, 2023
    Report Date
    July 25, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE CUSTOMER PROVIDED CLEANING, STERILIZATION, AND DISINFECTION INFORMATION. IT WAS NOTED, THE DEVICE IS STORED IN A ROOM TEMPERATURE, THE DEVICE WENT UNDER ADDITIONAL REPROCESSING IN ADDITION TO THE REPROCESSING IMMEDIATELY AFTER A PROCEDURE, WATER WAS ASPIRATED THROUGH THE INSTRUMENT/ SUCTION CHANNEL WITH A SUCTION PUMP, MANUAL CLEANING WAS PERFORMED WITHIN AN HOUR AFTER A PROCEDURE, THE DEVICE PASSED A LEAK TEST, THE DETERGENT SOLUTION USED FOR THE DEVICE IS ESCLIN AW, THE BRUSHED POINTS WERE THE INSTRUMENT CHANNEL AND THE SUCTION CHANNEL, THE DETERGENT SOLUTION USED FOR THE ENDOSCOPE WASHER DISINFECTOR VALIDATION (EWD/AER) PROCESS WAS ENDO QUICK, THE DISINFECTANT USED WAS RAPICIDE PA, ALL CHANNELS WERE CONNECTED WITH TUBES WHEN THE ENDOSCOPE WAS SET UP INTO THE AER/ EWD, THE WATER FILTER WAS REPLACED WITHIN THE SPECIFIED PERIOD, THE DEVICE WAS DRIED BY WIPING WITH STERILE PAPER AND BY THE DRYING PROCESS OF THE AER/EWD, AND THE SCOPE IS STORED WITHOUT DRYING CABINET. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON RESULTS OF THIRD PARTY TESTING, THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE USER SENT THE SUBJECT DEVICE TO A THIRD PARTY FOR CULTURE TESTING WHERE: SAMPLING FROM: N/A. COLONY FORMING UNIT (CFU): N/A. BACTERIAL IDENTIFICATION: ACINETOBACTER, NON-FERMENTATIVE BACTERIA. THE DEVICE WAS EVALUATED, WHERE NO ABNORMALITIES WERE FOUND, THAT COULD HAVE LED TO THE POSITIVE CULTURE. A FEW DEFECTS WERE NOTED, WHERE THE ANGULATION WAS INSUFFICIENT, CORROSION ON THE VENTING CONNECTOR, CORROSION INSIDE OF THE SCOPE CONNECTOR AND NOISE, DURING ANGULATION OPERATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED EVENT WAS NOT CONFIRMED, AS THE SCOPE WAS NOT MICROBIOLOGICALLY TESTED BY OLYMPUS. THE FOLLOWING IS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING MAINTENANCE, THE EVIS LUCERA ELITE BRONCHOVIDEOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE TEST OF THE SCOPE. SAMPLING OCCURRED DURING MAINTENANCE, BEFORE USE. THE CUSTOMER CONFIRMED THAT THE SCOPE HAS NOT BEEN USED ON A PATIENT AFTER THE BACTERIA WAS DETECTED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123632 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TQ290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown