BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 15910111 · Received December 2, 2022

    Report

    Report Number
    9610595-2022-04809
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    October 12, 2022
    Report Date
    January 11, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170339967
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION. ARTICLE: HTTPS://DOI.ORG/10.1016/J.JHIN.2022.09.024.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE THE UPDATES IN H6 AND H10. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿MICROBIOLOGICAL SURVEILLANCE POST-REPROCESSING OF FLEXIBLE ENDOSCOPES USED IN DIGESTIVE ENDOSCOPY: A NATIONAL STUDY,¿ SCOPES TESTED POSITIVE FOR MICROBIAL CONTAMINATION AFTER REPROCESSING. INTRODUCTION: MICROBIOLOGICAL SURVEILLANCE OF ENDOSCOPES IS A SAFETY MEASURE FOR VERIFYING THE QUALITY OF REPROCESSING PROCEDURES AND IDENTIFYING CONTAMINATED DEVICES, BUT DUODENOSCOPE-RELATED OUTBREAKS ARE STILL REPORTED. AIM: TO ASSESS THE EFFECTIVENESS OF DUODENOSCOPE REPROCESSING PROCEDURES IN ITALY. METHODS: BETWEEN DECEMBER 2019 AND APRIL 2020, DATA OBTAINED FROM MICROBIOLOGICAL SURVEILLANCE POST-REPROCESSING IN 15 ITALIAN ENDOSCOPY UNITS WERE COLLECTED. SAMPLING WAS CARRIED OUT AFTER REPROCESSING OR DURING STORAGE IN A CABINET. IN KEEPING WITH INTERNATIONAL GUIDELINES AND THE ITALIAN POSITION PAPER, THE MICRO-ORGANISMS WERE CLASSIFIED AS HIGH-CONCERN ORGANISMS (HCOS) AND LOW-CONCERN ORGANISMS (LCOS). FINDINGS: IN TOTAL, 144 SAMPLES WERE COLLECTED FROM 51 DUODENOSCOPES. OF THESE, 36.81% WERE CONTAMINATED: 22.92% WERE CONTAMINATED WITH HCOS AND 13.89% WERE CONTAMINATED WITH LCOS [2.08% WITH AN LCO LOAD OF 11E100 COLONY-FORMING UNITS (CFU)/DEVICE AND 0.69% WITH AN LCO LOAD OF >100 CFU/DEVICE]. THE CONTAMINATION RATE WAS 27.5% IN SAMPLES COLLECTED AFTER REPROCESSING, 40% IN SAMPLES COLLECTED DURING STORAGE IN A CABINET THAT WAS COMPLIANT WITH EN 16442:2015 (C-I), AND 100% IN SAMPLES COLLECTED DURING STORAGE IN A CABINET THAT WAS NOT COMPLIANT WITH EN 16442:2015 (NC-I). THE RESPECTIVE HCO RATES WERE 15.00%, 27.27% AND 66.67%. CORRELATION BETWEEN LCO CONTAMINATION AND STORAGE TIME WAS DEMONSTRATED (SPEARMAN¿S RHO¼0.3701; P¼0.0026). THE OLYMPUS DUODENOSCOPE TJFQ180V DEMONSTRATED THE LOWEST RATE OF CONTAMINATION (29.82%), ALTHOUGH THE CONTAMINATION RATE WAS 100% FOR DUODENOSCOPES STORED IN AN NC-I CABINET.CONCLUSION: MICROBIOLOGICAL SURVEILLANCE, ALONG WITH STRICT ADHERENCE TO REPROCESSING PROTOCOLS, MAY HELP TO DETECT ENDOSCOPE CONTAMINATION AT AN EARLY STAGE, AND REDUCE THE RISK OF DUODENOSCOPE-ASSOCIATED INFECTIONS.CASE WITH PATIENT IDENTIFIER (B)(6) REPRESENTS THE TJF-Q180V EVALUATED IN THE STUDY.CASE WITH PATIENT IDENTIFIER (B)(6 REPRESENTS THE TJF-Q160VR EVALUATED IN THE STUDY.CASE WITH PATIENT IDENTIFIER (B)(6) REPRESENTS THE TJF-145 EVALUATED IN THE STUDY.ADDITIONAL INFORMATION WAS REQUESTED FROM THE STUDY AUTHORS. ADDITIONAL INFORMATION PROVIDED INCLUDES: THE ARTICLE IS A NATIONAL MULTICENTER STUDY, SO WE CAN ONLY PROVIDE THE SERIAL NUMBER OF THE SCOPE FOR THEIR CENTER. FROM PISA CENTER ONLY ONE DUODENOSCOPE WAS OLYMPUS (TJF Q180V) WHICH PRESENTED K.PNEUMONIAE 10 CFU/CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676176 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170339967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown