BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 8824759 · Received July 24, 2019

    Report

    Report Number
    8010047-2019-02681
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    February 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION NOTED IN THE FULL COPY OF AN ARTICLE RECEIVED ON JANUARY 26, 2020. THE ARTICLE STATES THAT THE ERCPS WERE PERFORMED ON PATIENTS < 1 YEAR OLD TO MID-20S.

    Additional Manufacturer Narrative · 1

    THE ARTICLE DOES NOT PROVIDE SPECIFIC SERIAL NUMBERS FOR THE TJF OR PJF ENDOSCOPES USED IN THIS STUDY; THEREFORE, IT CANNOT BE CONFIRMED IF THE MENTIONED MODELS WERE RETURNED TO THE SERVICE CENTER FOR EVALUATION. INVESTIGATION IS ONGOING TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENTS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    ON JUNE 19, 2019 THE SERVICE CENTER RECEIVED AN ARTICLE TITLED "RESULTS OF DUODENOSCOPE CULTURE AFTER IMPLEMENTATION OF MANUFACTURER-RECOMMENDED REPROCESSING AND INFECTION SURVEILLANCE.¿ THE ARTICLE STATES THAT OUTBREAKS OF INFECTIONS TRANSMITTED BY DUODENOSCOPES HAVE PROMPTED CHANGES TO DUODENOSCOPE CLEANING PROTOCOLS. HOWEVER, LITTLE IS KNOWN ABOUT EFFECTIVENESS OF CLINICAL CLEANING PRACTICES. ACCORDING TO THE ARTICLE, CULTURE DATA WAS COLLECTED FROM DEC 2015 TO JULY 2018 AND WAS COMPARED TO THE USER FACILITY¿S PROSPECTIVE ENDOSCOPIC ADVERSE EVENT MONITORING SYSTEM DATA TO ASSESS FOR INFECTIONS RELATED TO ERCP. THE ARTICLE STATES THAT FOLLOWING MODELS TJF-Q180V, TJF-160 AND PJF-160 FROM THE USER FACILITY WERE CLEANED ACCORDING TO THE MANUFACTURER'S REPROCESSING MANUAL PROTOCOLS (IMMEDIATE BEDSIDE CLEANING FOLLOWED BY MANUAL CLEANING, TWO CYCLES OF AUTOMATED ENDOSCOPE REPROCESSOR CLEANING USING 22% HYDROGEN PEROXIDE AND 5% PEROXYACETIC ACID, 4.3% TRISODIUM PHOSPHATE, DETERGENT, THEN 70% ISOPROPYL ALCOHOL AND DRYING). THEN SAMPLES WERE TAKEN FROM THE DUODENSCOPE¿S DISTAL TIP, INCLUDING ELEVATOR MECHANISM AND STERILE WATER FLUSH THROUGH THE CHANNEL. ACCORDING TO THE AUTHOR, THE RESULTS SHOWED THAT THERE WERE 141 INSTANCES OF DUODENOSCOPE CLEANING, AND 282 CULTURES. THERE WERE 28 OF 236 (11.9%) INITIAL CULTURES WERE POSITIVE. THE SECOND CULTURES SHOWED 5 OF 36 (13.9%) WERE POSITIVE. THE THIRD SET OF CULTURES REVEALED 2 OF 8 (25%) WERE POSITIVE. SPECIMENS WERE GROWN IN BROAD CULTURE MEDIA. THE POSITIVE CULTURES WERE DEFINED AS >10 COLONY FORMING UNITS (CFUS)OF LOW-CONCERN ORGANISMS (COAGULASE NEGATIVE STAPHYLOCOCCI, MICROCOCCI, AND GRAM POSITIVE RODS)OR ANY CFUS OF HIGH-CONCERN ORGANISMS (YEAST, STAPHYLOCOCCUS AUREUS, ENTEROCOCCUS, OR GRAM-NEGATIVE ENTERIC BACILLI). THE AUTHOR REPORTS THAT IF EITHER CULTURE WAS POSITIVE, THE CLEANING, CULTURING, AND QUARANTINE STEPS WERE REPEATED UNTIL CULTURES WERE NEGATIVE, OR, IF EITHER OF THE 3RD SET OF CULTURES WAS POSITIVE, THE DUODENOSCOPE WAS RETURNED TO THE MANUFACTURER FOR ASSESSMENT. IN ADDITION, A TREATING ENDOSCOPIST WAS ABLE TO REMOVE THE DUODENOSCOPE EARLY FROM QUARANTINE IF CLINICALLY NECESSARY. THERE WERE NO PATIENTS WHO HAD SIGNIFICANT INFECTIONS AFTER ERCP. THIS IS 3 OF 35 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616789 EVIS EXERA DUODENOVIDEOSCOPE EVIS EXERA DUODENO VIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. PJF-160

    Patients

    Seq Age Sex Outcome Treatment
    1