BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19998743 · Received August 17, 2024

    Report

    Report Number
    9610595-2024-16503
    Event Type
    Injury
    Date Received
    August 17, 2024
    Date of Event
    July 30, 2024
    Report Date
    November 4, 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
    TX, US
    Reporter Occupation
    NURSE
    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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION IN A2, A3, A4, A5, B1, B2, B5, B7, D8, D10, G3, H1, H10 AND H11 AND CORRECTED DATA TO H6. THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS (B)(6). THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000406. 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 ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 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, 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 REPORTED THAT THE DISTAL COVER OF THE EVIS EXERA III DUODENOCIDEOSCOPE DETACHED INSIDE THE PATIENT AND COULD NOT BE RETRIEVED. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THAT FOLLOWING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT AND BALLOON DILATION THERE WERE ATTEMPTS TO RETRIEVE THE DISTAL END CAP. THE CUSTOMER USED ANOTHER SCOPE TO LOOK FOR THE DEVICE WITHOUT SUCCESS. ANOTHER DEVICE WAS ALSO USED TO LOCATE THE DEVICE BUT IT WAS NOT FOUND. THE CUSTOMER ALSO PERFORMED A CHEST AND KIDNEY, URETER AND BLADDER (KUB) X-RAY TO TRY AND LOCATE THE DEVICE BUT IT WAS NOT FOUND. THE PROCEDURE WAS COMPLETED IN THE NORMAL TIMEFRAME FOR THE PROCEDURE BUT THE SEDATION TIME WAS EXTENDED TO ALLOW FOR LOCATING AND RETRIEVING THE FALLEN DEVICE. THE PATIENT WAS ENCOURAGED TO USE A SPECIMEN HAT WHEN HAVING BOWEL MOVEMENTS BUT REFUSED. THE PATIENT WAS MONITORED IN A CLINICAL SETTING AND DISCHARGED WITH NO ISSUES. A SPECIMEN HAT WAS PROVIDED AT DISCHARGED AND HE WAS ENCOURAGED TO CONTACT THE FACILITY IF HE NOTICED A PASSING OF THE DEVICE. THE CUSTOMER REPORTS NO DIRECT INJURY TO THE PATIENT AFTER MONITORING PRIOR TO SAFELY DISCHARGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352649 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention EVIS EXERA III CV-190 602480574.| MAJ-2315.| MINDRAY INTUBATION GE HEALTHCARE 602480403.