BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 9289122 · Received November 7, 2019

    Report

    Report Number
    8010047-2019-03884
    Event Type
    Death
    Date Received
    November 7, 2019
    Date of Event
    February 29, 2016
    Report Date
    November 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170339967
    PMA / PMN Number
    K143153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS AUSTRALIA PTY LTD. (OAS) REVIEWED THE SALES RECORD AND FOUND THAT OLYMPUS DUODENOSCOPE TJF-Q180V WAS SOLD TO THE HOSPITAL IN 2010. THIS INFORMATION SUGGESTS THAT THE TJF-Q180V MIGHT HAVE BEEN UTILIZED IN THE PROCEDURE. DESPITE REPEATED OFFERS TO THE HOSPITAL FOR OLYMPUS¿ SERVICE, THE HOSPITAL DECLINED THESE OFFERS. THE TJF-Q180V WAS RETURNED TO OLYMPUS FOR MAINTENANCE BACK IN JULY 2016 AS A RECALL. THE MAINTENANCE RECORD SAYS THAT NON-OLYMPUS COMPONENTS WERE USED ON THE DEVICE. THE DEVICE GOT BACK TO THE MANUFACTURER'S SPECIFICATION IN THE MAINTENANCE AND WAS RETURNED TO THE HOSPITAL. THE DUODENOSCOPE MENTIONED IN THE ARTICLE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    ON OCTOBER 2ND, 2019, ABC NEWS PUBLISHED AN ARTICLE REGARDING A CLAIM LED IN THE SUPREME COURT AGAINST ST JOHN OF GOD HOSPITAL IN BENDIGO. ON OCTOBER 10TH, 2019, OLYMPUS AUSTRALIA PTY LTD. (OAS) BECAME AWARE OF THIS ARTICLE. THE ARTICLE STATES THAT THE PATIENT PASSED AWAY IN 2016 AFTER CONTRACTING A POST-OPERATIVE INFECTION FOLLOWING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO REMOVE REMAINING GALLSTONES. THE PATIENT PASSED AWAY WAS CAUSED BY SEPSIS DUE TO RAOULTELLA OMITHINOLYTICA FOLLOWING THE PROCEDURE. THE ARTICLE ALSO STATES "COURT DOCUMENTS ALLEGE THE HOSPITAL FAILED TO FOLLOW PROTOCOL WHICH REQUIRED THE "HIGH LEVEL OF DISINFECTION" OF THE DUODENOSCOPE, 12 HOURS PRIOR TO THE SURGERY." A CONVERSATION BETWEEN AN OLYMPUS STAFF MEMBER AND THE HOSPITAL INDICATES THAT AN OLYMPUS DUODENOSCOPE WAS USED IN THE PROCEDURE. OAS HAS TRIED TO CONTACT THE HOSPITAL FOR FURTHER DETAIL REGARDING THE MODEL NUMBER AND SERIAL NUMBER OF THE DEVICE, BUT THE CUSTOMER HAS DECLINED TO RESPOND. UNTIL THE PUBLICATION OF THIS ARTICLE, OLYMPUS DID NOT RECEIVE ANY COMPLAINTS ABOUT THIS INCIDENTS FROM THIS HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084278 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN 04953170339967

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death