BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 16494424 · Received March 7, 2023

    Report

    Report Number
    3002808148-2023-02163
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 4, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. CUSTOMER PROVIDE SOME INFORMATION ON REPROCESSING AT THE FACILITY. NO INFORMATION PROVIDED FOR PRE-CLEANING. DETERGENT USED FOR MANUAL CLEANING IS NEODISHER MULTIZYM BY DR. WEIGERT. BRUSHING IS PERFORMED FOR THE INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, AND DISTAL/AREAS AROUND THE ELEVATOR. MATERIALS USED ARE ASEPTIN MED 20-1790 AND 20-1798 SWABS AND OLYMPUS MAJ-1534 BRUSH. DISINFECTION OF THE DEVICE IS PERFORMED MANUALLY BY NEODISHER ENDODIS ACTIVE BY DR. WEIGERT. AUTOMATIC ENDOSCOPY REPROCESSOR (AER) DEVICE IS NOT USED. THE DEVICE IS STORED IN A PLASMA TYPHOON CABINET.

    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 FOUND 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 INSTRUCTION MANUAL OF GF-UCT180 DESCRIBES THE REPROCESSING METHODS IN THE FOLLOWING CHAPTERS: CHAPTER "COMPATIBLE REPROCESSING METHODS AND CHEMICAL AGENTS". CHAPTER "CLEANING, DISINFECTION, AND STERILIZATION PROCEDURES". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    AN INDEPENDENT LABORATORY PERFORMED FOR OLYMPUS A CULTURE TEST FOR THE DEVICE AFTER THE DEVICE WAS REPROCESSED PER THE DIRECTIONS OF THE INSTRUCTIONS FOR USE. THE TEST RESULTS FOR ALL CHANNELS AND THE DISTAL END INDICATE THAT THE CULTURE SAMPLING RESULTS CONFORM TO THE TARGET LEVELS ESTABLISHED BY THE FRENCH REGULATION OF (B)(6) 2016 WITH A NUMBER OF REVIVABLE MICROORGANISMS 3 CFU/ENDOSCOPE. THERE WAS A PRESENCE OF NON-TARGETED ORGANISM BACILLUS SPECIES MESOPHILES. THE MICROBIOLOGICAL QUALITY OF THE DEVICE IS SATISFACTORY, FOR THE PARAMETERS SOUGHT, FOR AN ENDOSCOPE SUBJECTED TO LEVEL DISINFECTION. THE DEVICE IS RETURNED, AND AN EVALUATION COMPLETED FOR IT. OBSERVATIONS FOR THE DEVICE: ACOUSTIC LENS HAD DAMAGE AND SCRATCHES; SWITCH KEY TOP 1 HAD UNCLEAR INDICATION; UNIVERSAL CORD WAS KINKED; AND ULTRASONIC CONNECTOR HAD PIN DAMAGE. THE USER¿S COMPLAINT WAS NOT CONFIRMED. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDENDUM (B)(6) 2023: CUSTOMER PROVIDED ADDITIONAL RESULTS FOR THE POSITIVE CULTURE TEST. THE RESULTS FOR ALL CHANNELS WERE AS BELOW: REVIVABLE MICROORGANISMS: GREATER THAN 80 CFU/ENDOSCOPE . INDICATOR MICROORGANISM STENOTROPHOMONAS MALTOPHILIA GREATER THAN 80 CFU/ENDOSCOPE.

    Description of Event or Problem · 0

    AS REPORTED BY THE CUSTOMER, AFTER A MICROBIOLOGICAL ROUTINE SAMPLING OF THIS DEVICE, CARRIED OUT AS REQUIRED BY FRENCH REGULATION, UNEXPECTED CONTAMINATION WAS DETECTED WHICH WAS ABOVE THE ACCEPTABLE THRESHOLD ALIGNING WITH THE ACTION LEVEL AS DETERMINED IN THE FRENCH REGULATION OF JULY 4, 2016. THE TEST WAS PERFORMED PRIOR TO USE. THERE WAS NO CONTAMINATION OR ANY OTHER DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE. TEST RESULTS OF FEB 6, 2023, FOR ERECTOR CHANNEL WERE AS FOLLOWS: REVIVABLE MICROORGANISMS: 13 CFU/ENDOSCOPE INDICATOR MICROORGANISM STENOTROPHOMONAS MALTOPHILIA 10 CFU/ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63483 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown