BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 17925979 · Received October 12, 2023

    Report

    Report Number
    9610595-2023-15077
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 15, 2023
    Report Date
    December 27, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170452024
    PMA / PMN Number
    K220587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 EXPLAINED THAT THE SCOPE WAS INITIALLY PUT THROUGH THE OER-PRO WASHER TWICE. THE SCOPE WAS THEN ETO STERILIZED AND AFTERWARDS TESTED POSITIVE FOR MOLD. THE SCOPE WAS THEN REPROCESSED, AND ETO STERILIZED AGAIN, AND THE SCOPE TESTED POSITIVE STILL FOR MOLD. REPROCESSING OCCURRED ON 12APR2023 AND ON 26APR2023. THE LOCATION OF THE SCOPE IN WHICH THE MOLD WAS DETECTED WAS UNKNOWN. THE CUSTOMER CONFIRMED THAT THERE WERE NO PATIENT INFECTIONS DUE TO THE REPORTED CONTAMINATION. THE CUSTOMER INDICATED THAT ALL AREAS OF THE SCOPE WERE CLEANED AS INSTRUCTED BY THE OLYMPUS CLEANING SPECIALIST (ESS). THE CUSTOMER SPECIFIED THAT AN IN-HOUSE SERVICE BY ESS OCCURRED FIVE TIMES THIS YEAR WITH THE LATEST VISIT BEING ON 14JUN2023. THE CUSTOMER CONFIRMED THAT THERE HAD BEEN NO CHANGES IN REPROCESSING PERSONNEL SINCE THE LAST IN-SERVICE TRAINING AND THAT ALL REPROCESSING PERSONNEL ARE TRAINED ON HOW TO PROPERLY REPROCESS AN ENDOSCOPE. DURING MANUAL CLEANING, THE FORCEPS ELEVATOR WAS BRUSHED AND FLUSHED. THE DETERGENT USED WAS PROLYSTICA. THE CUSTOMER CONFIRMED THAT THE ENDOSCOPE PASSED THE LEAK TEST. FOR AUTOMATED ENDOSCOPE REPROCESSOR (AER) TREATMENT, AN OER-PRO MACHINE (2834209) IS USED WITH ACECIDE-C DETERGENT AND AN UNKNOWN (DISINFECTANT). THE SCOPE IS STORED IN AN UNSPECIFIED DRYING CABINET. THE CUSTOMER CONFIRMED THAT ALL CHANNELS WERE CONNECTED WITH TUBES WHEN THE ENDOSCOPE WAS SETTING INTO THE AER. THE CUSTOMER CONFIRMED THAT THE SCOPE IS ETO STERILIZED. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION, HOWEVER AS OF THIS REPORT THE RESULTS OF THIS EVALUATION ARE NOT YET COMPLETE. ONCE THE RESULTS OF THIS INVESTIGATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THIRD-PARTY TESTING, THE DEVICE EVALUATION, AND THE LEGAL MANUFACTURER'S INVESTIGATION. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: NOV 03, 2023. SAMPLING FROM: BIOPSY CHANNEL//SUCTION CHANNEL. CFU: UNKNOWN. BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS, MICROCOCCUS YUNNANENSIS. THE RETURNED DEVICE WAS EVALUATED AND THE FOLLOWING DEFECTS WERE NOTED DURING THE EVALUATION: THE FORCEPS PASSAGE WAS KINKED/SCRATCHED, BENDING SECTION COVER WAS FLABBY, BENDING SECTION COVER GLUE WAS CRACKED, THERE WERE SCRATCHES IN THE SUCTION FLOW, AND LABEL/TAPE WAS FOUND ON THE LIGHT GUIDE TUBE. THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. 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. ALTHOUGH THE USER CULTURE RESULTS WERE NOT SHARED THE REPORTED ISSUE WAS CONFIRMED AS AN UNSPECIFIED AMOUNT BACTERIA WAS FOUND WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR. THE CAUSE OF THE BACTERIA AND DRY RESIDUE REMAINING ON THE DEVICE COULD NOT BE SPECIFIED. AS THERE WERE REPORTED DEVIATIONS IN REPROCESSING, IT IS LIKELY THERE WAS CROSS CONTAMINATION DURING SAMPLING. IT WAS ALSO REPORTED THAT THE CUSTOMER BELIEVES THE "MOLD" CAME FROM OLYMPUS AS THE SCOPE WAS CULTURED IMMEDIATELY AFTER RECEIPT FROM OLYMPUS. AN ENDOSCOPIC SUPPORT SPECIALIST WAS SENT TO THE USER FACILITY TO ENSURE REPROCESSING TECHNIQUE AND CONFIRMED NO CORRECTIONS WERE NEEDED. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA III DUODENOVIDEOSCOPE TESTED POSITIVE FOR UNEXPECTED CONTAMINATION. DURING THE SAMPLING, THE SCOPE TESTED POSITIVE FOR UNKNOWN COLONY FORMING UNITS (CFUS) OF UNSPECIFIED MOLD. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286020 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170452024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown