BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15099029 · Received July 25, 2022

    Report

    Report Number
    9610595-2022-00254
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 14, 2022
    Report Date
    October 21, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER THE DEVICE WAS RETURNED TO OLYMPUS, IT WAS SENT OUT FOR ADDITIONAL TESTING. THE HYGIENE MICROBIOLOGICAL INVESTIGATION REPORT INDICATED THE CHANNELS OF THE SCOPE WERE CULTURED. THE RESULTS OBTAINED COMPLY WITH THE TARGET LEVEL FOR AN ENDOSCOPE SUBJECTED TO HIGH LEVEL DISINFECTION AND RINSED WITH STERILE WATER. THE SUBJECT DEVICE WAS THEN RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, SERVICE FOUND THE DISTAL END COVER WAS SCRATCHED. THE ADHESIVE WAS SEPARATED FROM THE BENDING RUBBER. KEY TOP #1 WAS WORN. THE SCOPE CONNECTOR PLUG UNIT WAS DENTED. THE UP/DOWN ANGULATION KNOB DID NOT MEET SPECIFICATION. THE BIOPSY CHANNEL WAS REPLACED AS PART OF PREVENTIVE MAINTENANCE. THE CUSTOMER'S CLEANING, DISINFECTING, AND STERILIZATION (CDS) PROCESSES WERE REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED, AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON RESULTS OF THIRD PARTY TESTING AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE FOLLOWING WAS RESULT OF THE CULTURE TEST PERFORMED AT THE THIRD-PARTY LABS, PROVIDED FROM OLYMPUS: SAMPLING FROM: ALL CHANNELS. CFU: 1CFU. BACTERIAL IDENTIFICATION: MICROCOCCACEAE. 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 SAME GERMS WERE NOT DETECTED AND 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ROUTINE TESTING, THE ENDOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. ON (B)(6), 2022, 79 COLONY FORMING UNITS (CFU) OF ENTEROBACTER CLOACAE WERE DETECTED IN THE SUCTION AND BIOPSY CHANNELS. ON (B)(6) 2022, 175 CFUS OF ENTEROBACTER CLOACAE WERE DETECTED IN THE SUCTION AND BIOPSY CHANNELS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637953 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown