BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 16341707 · Received February 9, 2023

    Report

    Report Number
    9610595-2023-02153
    Event Type
    Death
    Date Received
    February 9, 2023
    Date of Event
    May 9, 2016
    Report Date
    June 2, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K220587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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 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, SINCE THE DEVICE WAS NOT RETURNED FOR AN EVALUATION, AND NO ADDITIONAL EVENT DETAILS COULD BE OBTAINED, A RELATIONSHIP BETWEEN THE SUBJECT SCOPE AND THE REPORTED EVENT COULD NOT BE IDENTIFIED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ¿OPERATION MANUAL; IMPORTANT INFORMATION. INDICATIONS FOR USE: TJF-Q190V MODEL SCOPE IS DESIGNED TO BE USED FOR ENDOSCOPY AND ENDOSCOPIC SURGERY WITHIN THE DUODENUM. ¿PRECAUTION: DO NOT USE THIS ENDOSCOPE FOR ANY PURPOSE OTHER THAN ITS INDICATIONS FOR USE.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    A REPRESENTATIVE DUODENOSCOPE WAS CHOSEN AS THE MODEL/SERIAL NUMBER WERE NOT REPORTED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS REPORT WAS SUBMITTED BY THE IMPORTER UNDER THE IMPORTER'S REPORT NUMBER: 2429304 - 2023 - 00018.

    Description of Event or Problem · 0

    A CONSUMER REPORTED TO OLYMPUS THAT AFTER THE USE OF AN UNKNOWN DUODENOSCOPE, THE PATIENT EXPIRED DUE TO AN INFECTED SCOPE. THE PATIENT INITIALLY HAD HIP SURGERY AFTER FALLING OUT OF A CAR. A BONE CHIPPED AND IT WAS STATED THEY USED A SCOPE AT THAT TIME. IT WAS REPORTED THAT THERE WAS PUS AND THE PATIENT HAD TO RETURN SEVERAL TIMES TO HAVE THE PUS "REMOVED." IT WAS ALSO STATED THAT AN OLYMPUS SCOPE WAS USED EVERY INSTANCE HE WENT TO THE HOSPITAL. AT ONE POINT, THE PATIENT'S CLOSET IN THE HOSPITAL ROOM WAS SEARCHED AS IT WAS REPORTED THAT HOSPITAL STAFF WERE "LOOKING FOR A SCOPE." THE PATIENT WAS ON NEOMYCIN BUT NO SPECIFICS ON TREATMENT WERE AVAILABLE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM ON (B)(6) 2016 AFTER AN UNSPECIFIED PROCEDURE AND 5 MINUTES LATER A CODE BLUE OCCURRED AND THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346809 EVIS EXERA III DUODENOVIDEOSCOPE FLEXIBLE VIDEO DUODENOSCOPE, REUSABLE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| D| H