BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 20100511 · Received August 29, 2024

    Report

    Report Number
    9610595-2024-17360
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 12, 2024
    Report Date
    November 4, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K220587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION, BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO PROVIDE AN UPDATE TO FIELD (D8). 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, IT IS LIKELY, THE REPORTED EVENT OCCURRED, DUE TO THE FOLLOWING: DISTAL COVER WAS NOT INSTALLED PROPERLY. FRICTION STRESS, SUCH AS TWISTING, PUSHING, PULLING THE DEVICE IN BODY CAVITY AND/OR STRESS BY CONTACTING WITH MOUTHPIECE, ETC. WERE APPLIED TO THE DISTAL COVER, DURING THE PROCEDURE. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED. AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED, BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: OPERATION-PRECAUTIONS: PREPARATION AND INSPECTION, ATTACHING ACCESSORIES TO THE ENDOSCOPE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000393. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL COVER FELL OFF FROM THE DUODENOVIDEOSCOPE AND INTO THE PATIENT IN THE MIDDLE OF A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PATIENT'S ANESTHESIA WAS EXTENDED BY ABOUT 15 MINUTES DUE TO THE ADDITIONAL PROCEDURE TO RETRIEVE THE FALLEN COVER. THE ERCP WAS COMPLETED WITH A DIFFERENT DISTAL COVER. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095989 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention MAJ-2315/H3X12-SINGLE USE DISTAL COVER