BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 17228697 · Received June 29, 2023

    Report

    Report Number
    9610595-2023-09519
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    March 16, 2023
    Report Date
    June 29, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170416118
    PMA / PMN Number
    K192793
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING AND RESULTS ARE STILL PENDING. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE CUSTOMER IS CURRENTLY BEING PERFORMED. AFTER CULTURE TESTING, THE DEVICE WILL BE EVALUATED.THE CUSTOMER PROVIDED THE CLEANING, DISINFECTION, AND STERILIZATION PROCESS STATING THAT PRECLEANING WAS PERFORMED IMMEDIATELY AFTER THE PROCEDURE. WATER WAS ASPIRATED THROUGH THE INSTRUMENT/SUCTION CHANNEL WITH A SUCTION PUMP. DURING MANUAL CLEANING, THE DETERGENT USED WAS ENDOQUICK. THE SUCTION AND BIOPSY PORT AND VALVE WERE BRUSHED. THE DISINFECTANT USED WAS ACECIDE C. THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) USED WAS OER PRO SN 2110646 WITH ENDOQUICK DETERGENT AND ACECIDE C DISINFECTANT. THE DEVICE WAS STORED IN A VENTILATED, ENDOSCOPE-DEDICATED, ENCLOSED CABINET. OLYMPUS IS THE MAINTENANCE COMPANY. THE CLEANING, DISINFECTION, AND STERILIZATION (CDS) WAS PERFORMED BY THE CUSTOMER.ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2023-00201.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA III COLONOVIDEOSCOPE WAS USED WITH A PATIENT WHO LATER ALLEGED CONTRACTING HEPATITIS B FROM THE DEVICE. THE DEVICE WAS USED DURING A DIAGNOSTIC COLONOSCOPY. THE PATIENT IS NOW BEING FOLLOWED BY HEPATOLOGY AND GASTROENTEROLOGY. AS THE FACILITY DOES NOT PERFORM ROUTINE CULTURING OF THE SCOPE, THEY HAVE SENT THE DEVICE TO A THIRD PARTY LAB FOR CULTURING AND TESTING. THE USER DID NOT REPORT ANY OTHER CONTAMINATION OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY OTHER PERSON TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527566 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-HQ190L 04953170416118

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Disability