BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 17001336 · Received May 25, 2023

    Report

    Report Number
    9610595-2023-08021
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    April 21, 2023
    Report Date
    June 29, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170202339
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H3 AND H6 INVESTIGATION TYPE, ON 04MAY2023, A TECHNICIAN WAS ON SITE AND NOTED AN EXPIRED CANISTER OF SCHÜLKE & MAYR THERMOSEPT ER IN THE ETD MACHINE. (EXPIRATION DATE 10/2022) AFTER REPLACEMENT, A SECOND HMI CHECK WAS PERFORMED ON THE TWO ETDS AND 4 ENDOSCOPES. ALL TESTS WERE NEGATIVE, NO GERMS WERE FOUND. THEREFORE, THE DEVICE WAS NOT SENT TO OLYMPUS TO BE EVALUATED. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE CUSTOMER COMPLETED CDS CHECKLIST (PLEASE SEE B5) AND 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 FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER THE EXPIRED CLEANING SOLUTION WAS REPLACED, 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

    THE DEVICE WAS NOT RETURNED. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED THE CLEANING STERILIZATION AND DISINFECTION (CDS) PROCESSES PERFORMED AT THE USER FACILITY. THE CUSTOMER DID CONFIRM THAT THERE WERE NO DEVIATIONS OR DEFICIENCIES CONCERNING REPROCESSING OF THE SCOPE. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THERE WERE NO SUSPECTED PATIENT INFECTIONS DUE TO THE FACILITY FINDINGS. THE CUSTOMER DID NOT PROVIDE THE SPECIFIC STEPS TAKEN DURING THE CDS PROCESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT PATHOGENS WERE DETECTED ON TWO ENDO THERMOS DISINFECTORS (ETD) AND FOUR ENDOSCOPES USED AT THE FACILITY DURING THE HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) INSPECTION. THE CUSTOMER THEN CONTACTED OLYMPUS AND REQUESTED AN INSPECTION OF THE ETDS. A TECHNICIAN WAS ON SITE AND CHECKED THE TWO ETDS. A SECOND HMI CHECK ON THE TWO ETDS AND FOUR ENDOSCOPES WAS PERFORMED. AFTER THE SECOND HMI TEST, ALL RESULTS WERE NEGATIVE. NO PATHOGENS WERE FOUND. 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. THIS COMPLAINT # (B)(4). CAPTURES A REPORT ON EVIS EXERA II COLONOVIDEOSCOPE MODEL: CF-H180AL:, SERIAL NUMBER: (B)(6). THE RINSING LIQUID ENDOSCOPE - AIR-WATER CHANNEL, THE FLUSHING LIQUID ENDOSCOPE - INSTRUMENTATION CHANNEL, RINSING LIQUID ENDOSCOPE-OPTICS RINSING SOLUTION AND SWAB ENDOSCOPE -DISTAL END/VALVE INLET WERE CULTURED. AS PER THE FIRST HMI REPORT RESULT DATED: (B)(6) 2023, THE AIR/WATER CHANNEL TESTED POSITIVE FOR (5.1) COLONY FORMING UNITS (CFU) PER MILLILITER OF PANTOEA AGGLOMERANS. THE TOTAL NUMBER OF COLONIES IDENTIFIED WAS WELL ABOVE THE GUIDELINE VALUE OF 1 CFU/ML. THE TEST ALSO INCLUDED TESTING FOR INDICATOR GERMS SUCH AS ENTEROCOCCI, ENTEROBACTERIACEAE, PSEUDOMONADS AND OTHERS. NON-FERMENTERS, GREENING STREPTOCOCCI, AND OTHER HYGIENE-RELEVANT PATHOGENS SUCH AS STAPHYLOCOCCUS AUREUS. THE FOLLOWING INDICATOR GERMS WERE DETECTED: E. COLI, ENTEROCOCCI AND ENTEROBACTERIACEAE: THE DETECTION OF BACTERIA THAT ARE PART OF THE INTESTINAL FLORA INDICATES INSUFFICIENT CLOSE CLEANING AND DISINFECTION. A SECOND HMI TEST WAS CONDUCTED APPROXIMATELY TWO WEEKS LATER. THE AIR WATER CHANNEL AND INSTRUMENT CHANNEL WERE TESTED, AND NO HYGIENE-RELEVANT MICROORGANISMS WERE DETECTED. COMPLAINT ON OTHER ENDOSCOPES CAPTURED IN RELATED PATIENT IDENTIFIERS: (B)(6) (MODEL: GIF-Q145; SERIAL NUMBER: (B)(6). (B)(6) (MODEL: GIF-H180J; SERIAL NUMBER: (B)(6). (B)(6) (MODEL: GIF-Q165; SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516160 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H180AL 04953170202339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown