BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 16791508 · Received April 21, 2023

    Report

    Report Number
    9610595-2023-06509
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Report Date
    July 11, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170339325
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE REPORTED THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "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.

    Additional Manufacturer Narrative · 0

    AS OF THIS REPORT, OLYMPUS HAS NOT RECEIVED THIRD-PARTY TEST RESULTS TO CONFIRM THIS ALLEGATION. THE CUSTOMER PROVIDED THE CLEANING STERILIZATION AND DISINFECTION (CDS) PROCESSES PERFORMED AT THE USER FACILITY. THE CUSTOMER DID NOT PROVIDE THE STEPS TAKEN DURING THE PRE-CLEANING PROCESS. DURING THE MANUAL CLEANING PROCESS, THE CUSTOMER USES MULTIENZYM DETERGENT AND BRUSHES THE INSTRUMENT CHANNEL, SUCTION CYLINDER, AND INSTRUMENT CHANNEL PORT. THE CUSTOMER DID NOT SPECIFY THE BRUSHES USED DURING THE MANUAL CLEANING PROCESS. IT WAS NOT SPECIFIED IF THE SCOPE IS MANUALLY DISINFECTED. FOR AUTOMATED ENDOSCOPE REPROCESSOR (AER) TREATMENT, AN OLYMPUS RDG-E MACHINE IS USED WITH OLYMPUS ENDO DETERGENT AND OLYMPUS ENDO DIS (DISINFECTANT). THE SCOPE IS DRIED BY WIPING WITH CLEAN TOWEL/ PAPER AND AIR DRIED BY CLEAN COMPRESSED AIR. THE SCOPE IS STORED IN A ENDOSKOPLAGERSCHRANK STORAGE. THE CUSTOMER CONFIRMED THAT THE WATER QUALITY OF THE RINSE WATER WAS CONTROLLED WITH UV LIGHT. IT WAS INDICATED THAT THE WATER FILTER WAS NOT REPLACED PERIODICALLY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) OLYMPUS IS THE MAINTENANCE COMPANY USED BY THE CUSTOMER. THE SCOPE WAS NOT STERILIZED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON RESULTS OF THIRD PARTY TESTING AND THE DEVICE EVALUATION. OLYMPUS SENT THE SUBJECT DEVICE TO A THIRD PARTY FOR CULTURE TESTING WHERE: SAMPLING FROM: DISTAL END CFU: 0CFU. BACTERIAL IDENTIFICATION: N/A, SAMPLING FROM: INSTRUMENT / BIOPSY / SUCTION CHANNEL. CFU: 0CFU. BACTERIAL IDENTIFICATION: N/A. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. MULTIPLE DEFECTS WERE NOTED WHERE: BENDING SECTION COVER ADHESIVE WAS CHIPPED. THE UP DOWN PLATE WAS DISCOLORED. THE SWITCH BOX UNIT HAD A SHORT CABLE. THE ANGULATION WAS OUT OF SPECIFICATION. THE ANGLE WIRES WERE STRETCHED. POOR IMAGE, DUE TO BREAKAGE OF THE IMAGE SENSOR. HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II BRONCHOVIDEOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THE SCOPE WAS SAMPLED ONE TIME. DURING THE SAMPLING, THE SCOPE TESTED POSITIVE FOR 40,000 KOLONIEBILDENDE EINHEIT (KBE)/ US CONVERSION - COLONY FORMING UNITS (CFUS) OF STAPHYLOCOCCUS HOMINIS. THE ISSUE WAS FOUND AT REPROCESSING IN THE RINSING FLUID. THE USER DID NOT REPORT ANY PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865543 EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1T180 04953170339325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown