BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 20047127 · Received August 23, 2024

    Report

    Report Number
    9610595-2024-16832
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    August 12, 2024
    Report Date
    November 5, 2024
    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
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER AS REFLECTED IN B5. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000404-1.

    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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION TO THE INITIAL MDR WITH INFORMATION INADVERTENTLY LEFT OUT. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000404. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE CORRECTION TO THE PREVIOUS SUPPLEMENTAL REPORT FIELDS (H6 AND H11). CORRECTION TO THE PREVIOUS H6 AND H11 AS CODE 3331 WAS INADVERTENTLY SELECTED. ADDITIONALLY, 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.

    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, 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.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT THE ISSUE OCCURRED IN THE MIDDLE OF AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS DELAYED FOR AN UNSPECIFIED TIME TO RETRIEVE THE COVER AND WAS THEN COMPLETED WITH A NEW DISTAL COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE DUODENOVIDEOSCOPE DISTAL END COVER DROPPED OUT. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL COVER FELL OFF FROM THE DUODENOVIDEOSCOPE AND INTO THE PATIENT. THE CUSTOMER RETRIEVED THE DISTAL COVER SUCCESSFULLY WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698625 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

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