BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 11761030 · Received May 3, 2021

    Report

    Report Number
    8010047-2021-05755
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Report Date
    July 13, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE MANUFACTURING DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. HOWEVER, OLYMPUS ONLY SHIPS DEVICES THAT HAVE BEEN MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. THE UDI IS NOT AVAILABLE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED OMSC FOR EVALUATION.

    Description of Event or Problem · 1

    IT IS REPORTED IN THE ARTICLE "SURVEILLANCE OF GUIDELINE PRACTICES FOR DUODENOSCOPE AND LINEAR ECHOENDOSCOPE REPROCESSING IN A LARGE HEALTHCARE SYSTEM", SCOPES TESTED POSITIVE FOR PATHOGENS AFTER BEING REPROCESSED. THE AIM OF THE STUDY: TO ASSESS THE ADEQUACY OF CURRENTLY RECOMMENDED DUODENOSCOPE AND LINEAR ECHOENDOSCOPE (DLE) AUTOMATIC ENDOSCOPE REPROCESSING (AER) AND HIGH-LEVEL DISINFECTION (HLD), WE COLLECTED DAILY POST-REPROCESSING SURVEILLANCE CULTURES OF 106 DLES IN 21 PROVIDENCE AND AFFILIATE HOSPITALS. METHODS: DAILY QUALITATIVE SURVEILLANCE OF DRIED, POST-HLD DLES WAS CONDUCTED FOR A MINIMUM OF 30 DAYS AT EACH FACILITY. POSITIVITY RATES FOR ANY MICROBIAL GROWTH AND GROWTH OF HIGH-CONCERN PATHOGENS WERE REPORTED. POTENTIAL EFFECTS OF DLE MANUFACTURER, AGE, AND AER PROCESSOR ON CULTURE-POSITIVITY RATE WERE ASSESSED. RESULTS: MICROBIAL GROWTH WAS RECOVERED FROM 201 OF 4032 SPECIMENS (5%) OR 189 OF 2238 ENCOUNTERS (8.4%), INCLUDING 23 SPECIMENS (.6%) OR 21 ENCOUNTERS (.9%) FOR A HIGH-CONCERN PATHOGEN. WIDE VARIATIONS IN CULTURE POSITIVITY RATE WERE OBSERVED ACROSS FACILITIES. NO STRIKING DIFFERENCE IN CULTURE-POSITIVITY RATE WAS SEEN AMONG 8 DLE MODELS, 3 DLE MANUFACTURERS, DLE AGE, MANUAL OR BEDSIDE CLEANSER, OR AUTOMATIC FLUSHING SYSTEM USE. HOWEVER, THERE WAS SUGGESTIVE EVIDENCE THAT CUSTOM ULTRASONICS AER (WARMINSTER, PA, USA) HAD A LOWER CULTURE-POSITIVITY RATE THAN MEDIVATORS AER (CANTEL MEDICAL CORP., LITTLE FALLS, NJ, USA) FOR HIGH-CONCERN PATHOGEN GROWTH (0/1079 VS 21/2735 SPECIMENS OR 0/547 VS 20/1582 ENCOUNTERS). TWO ENDOSCOPES GREW INTESTINAL FLORA ON SEVERAL OCCASIONS DESPITE MULTIPLE HLD. NO MULTIDRUG-RESISTANT ORGANISM WAS DETECTED. CONCLUSIONS: IN THIS MULTICENTER DLE SURVEILLANCE STUDY, MICROBIAL GROWTH WAS RECOVERED IN 5.0% OF SPECIMENS (8.4% OF ENCOUNTERS), WITH MOST BEING ENVIRONMENTAL MICROBES. ENTERIC BACTERIAL FLORA WAS RECOVERED IN .6% OF SPECIMENS (.9% OF ENCOUNTERS), DESPITE COMPLIANCE WITH 2014 U.S. GUIDELINES AND MANUFACTURERS¿ RECOMMENDATIONS FOR CLEANING AND HLD PROCESS. THE OBSERVED BETTER PERFORMANCE OF CUSTOM ULTRASONICS AER DESERVES FURTHER INVESTIGATION. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-Q160 SCOPES WITH POSITIVE CULTURES AFTER REPROCESSING. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS TJF-Q180 SCOPES WITH POSITIVE CULTURES AFTER REPROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656291 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160F

    Patients

    Seq Age Sex Outcome Treatment
    1