BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 14163540 · Received April 20, 2022

    Report

    Report Number
    8010047-2022-06719
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    August 6, 2020
    Report Date
    May 27, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE STATES DUODENOSCOPE, EITHER JF-260V OR TJF-260V, JF-260V WAS CHOSEN AS THE REPRESENTATIVE DEVICE. 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 · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT 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: USE OF PROTON PUMP INHIBITORS AND CHOLANGITIS COMPLICATED WITH MULTI-DRUG RESISTANT BACTERIA,¿ PATIENTS EXPERIENCED MULTIDRUG RESISTANT BACTERIAL INFECTIONS AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES USING OLYMPUS DUODENOSCOPES. STUDY BACKGROUND/AIM: MULTIDRUG-RESISTANT BACTERIA (MDRB) HAS RAPIDLY SPREAD WORLDWIDE AND BECOME A SERIOUS PROBLEM. PROTON PUMP INHIBITORS (PPIS) ARE A CLASS OF COMMONLY PRESCRIBED MEDICATIONS, BUT RECENT STUDIES HAVE SUGGESTED THE INCREASED RISK OF INFECTION WITH MDRB IN PPI USERS. THIS STUDY EVALUATED THE ASSOCIATION BETWEEN PPI USE AND INCIDENCE OF CHOLANGITIS WITH MDRB. METHOD: CONSECUTIVE PATIENTS WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BETWEEN JANUARY 2010 AND AUGUST 2019 WERE INCLUDED IN THIS RETROSPECTIVE STUDY. THE INCIDENCE OF CHOLANGITIS WITH MDRB WAS COMPARED BETWEEN REGULAR AND NON-REGULAR PPI USERS. RESULTS: A TOTAL OF 1224 REGULAR PPI USERS AND 1528 NON-REGULAR PPI USERS WERE IDENTIFIED. THERE WAS NO CLINICALLY SIGNIFICANT DIFFERENCE IN AGE AND SEX BETWEEN THE GROUPS. INDICATION OF ERCP WAS DIFFERENT BETWEEN THE GROUPS. THE NUMBER OF ERCP SESSIONS DURING THE STUDY PERIODS WAS HIGHER IN REGULAR PPI USERS. THE INCIDENCE OF CHOLANGITIS WITH MDRB WAS SIGNIFICANTLY HIGHER IN REGULAR PPI USERS (3.0% VS 1.1%; P < .001). MULTIVARIABLE-ADJUSTED ODDS RATIO FOR CHOLANGITIS WITH MDRB COMPARING REGULAR PPI USERS TO NON-REGULAR USERS WAS 2.19 (95% CONFIDENCE INTERVAL 1.20-4.00; P = .01). CONCLUSION: REGULAR PPI USE WAS ASSOCIATED WITH A HIGHER RISK OF CHOLANGITIS WITH MDRB. FIFTY-FOUR PATIENTS DEVELOPED CHOLANGITIS WITH MDRB DURING THE STUDY PERIOD. REGULAR PPI USERS HAD A SIGNIFICANTLY HIGHER INCIDENCE OF CHOLANGITIS WITH MDRB PARED WITH NON-PPI USERS (3% VS. 1.1%) THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265590 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R