BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 16680162 · Received April 5, 2023

    Report

    Report Number
    3002808148-2023-03320
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 5, 2023
    Report Date
    May 17, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLEANING, DISINFECTION, AND STERILIZATION CDS WAS PERFORMED BY THE CUSTOMER. THERE WAS NO PATIENT INFECTION. PRE-CLEANING INVOLVED ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL AND FLUSHING OF THE AIR/WATER, AUXILIARY, BALLOON AND FORCEPS ELEVATOR CHANNELS. ANIOSYME SYNERGIE S WAS USED AS THE DETERGENT FOR PRECLEANING. NO MANUAL CLEANING WAS DONE. AN ASEPT INMED REF: (B)(4), LOT 220556 BRUSH WAS USED. NO MANUAL DISINFECTION WAS DONE. AN POKA YOKE AUTOMATIC ENDOSCOPE REPROCESSOR WAS USED. THE SCOPE WAS STORED IN A SOLUSCOPE DRYING CABINET. THE SCOPE WAS NOT STERILIZED. AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE MICROBIOLOGICAL ANALYSIS REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED AND THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE ACOUSTIC LENS WAS DAMAGED. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON A CORRECTION TO RESULTS OF THIRD-PARTY TESTING (PLEASE SEE B6) 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 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING REGULAR EXAMINATION IN THE HOSPITAL. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258233 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown