BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 11815475 · Received May 12, 2021

    Report

    Report Number
    2951238-2021-00336
    Event Type
    Injury
    Date Received
    May 12, 2021
    Report Date
    December 7, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170335181
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 01-APR-2021.

    Description of Event or Problem · 1

    IT IS REPORTED AN UNKNOWN TIME PERIOD AFTER A PROCEDURE USING AN EVIS EXERA III BRONCHOVIDEOSCOPE, THE PATIENT EXPERIENCED AN INFECTION. THE CUSTOMER STATED, IT WAS INITIALLY VERY CONCERNING THAT THE SAME SCOPE WAS USED ON 5 OF THE 6 PATIENTS IN THIS POTENTIAL PSEUDO-EPIDEMIC. HOWEVER, THERE WAS NO GROWTH FROM THE BRONCHOSCOPE TIP SUBMERGED FOR ENRICHMENT IN TRYPTIC SOY BROTH, NOR FROM STERILE SALINE RINSES PASSED THROUGH THE UPPER AND LOWER CHANNELS AND PLATED ONTO BLOOD AGAR, SABAROUD DEXTROSE AGAR, 7H11 AGAR AND 7H9 BROTH IN AN ATTEMPT TO RECOVER NON-FASTIDIOUS BACTERIA, FUNGI AND MYCOBACTERIA. AFTER INITIAL CULTURES WERE SET UP, WE ASKED THAT THE SCOPE BE REMOVED FROM USE AND RETURNED TO THE VENDOR FOR INSPECTION SINCE IT HAD FAILED LEAK TESTS TWICE WITHIN A 6 MONTH INTERVAL LAST YEAR, AND SUBSEQUENTLY HAD CHANNELS REPLACED BY THE VENDOR. THE CONCERN WAS THAT DAMAGE OR GAPS IN COMPONENTS MIGHT RETAIN BIOBURDEN AND LEAD TO HIGH LEVEL DISINFECTION FAILURE. I HAVE NOT HEARD ANYTHING YET REGARDING THE VENDOR¿S INSPECTION, BUT IT IS REASSURING THAT INITIAL CULTURE DOES NOT POINT TO AN OBVIOUS ISSUE WITH THIS SCOPE. IT IS POSSIBLE THAT HLD FAILURES COULD BE INFREQUENT/INTERMITTENT SO IT WILL BE GOOD TO REVIEW WORK PRACTICES TO ENSURE WE¿RE CONSISTENTLY FOLLOWING PROTOCOL. RATHER THAN AN INDICATION OF INFECTION RISK, IT MAY BE THAT THIS SCOPE IS PREFERENTIALLY USED. PATIENT 1 OF 5 IS REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6). PATIENT 2 OF 5 IS REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6). PATIENT 3 OF 5 IS REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6). PATIENT 4 OF 5 IS REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6). PATIENT 5 OF 5 IS REPORTED IN CASE WITH PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708820 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TH190 04953170335181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other