BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19025922 · Received April 2, 2024

    Report

    Report Number
    9610595-2024-06887
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 21, 2024
    Report Date
    May 20, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    PMA / PMN Number
    K220587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED THE COMPONENT CODE FROM COVER TO TIP.

    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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION AND PAST INVESTIGATION RESULTS, IT IS LIKELY THE SUGGESTED EVENT OCCURRED DUE TO ONE OF THE FOLLOWING MECHANISMS. DISTAL COVER WAS NOT PROPERLY ATTACHED. 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, A SPECIFIC ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE IDENTIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: OPERATION MANUAL CHAPTER 4 SECTION 4.1 STATES DETECTION METHODS. OPERATION MANUAL CHAPTER 3 SECTION 3.5 STATES PREVENTIVE MEASURES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE DISTAL COVER FELL INTO THE PATIENT¿S MOUTH WHEN WITHDRAWING THE DUODENOVIDEOSCOPE FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE IT FROM THE PATIENT¿S MOUTH. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019254 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female MAJ-2315 SINGLE USE DISTAL COVER