BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 20318230 · Received September 27, 2024

    Report

    Report Number
    9610595-2024-19363
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2024
    Report Date
    November 7, 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
    RI, US
    Reporter Occupation
    501

    Narratives

    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 IS RELATED TO THE FOLLOWING PATIENT IDENTIFIER:(B)(6). THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000422.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE DISTAL COVER LIKELY DETACHED FROM THE SCOPE DUE TO THE FOLLOWING: 1. THE COVER WAS NOT INSTALLED PROPERLY. 2. STRESS FROM FRICTION CAUSED BY TWISTING AND PUSHING AND PULLING INSIDE THE BODY CAVITY, OR INTERFERENCE WITH THE MOUTHPIECE, WAS APPLIED TO THE COVER DURING PROCEDURE. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) IN SECTION: 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 DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH CANNULATION OF THE DUCT, WIRE PLACEMENT, REMOVAL OF PLASTIC STENT, PLACEMENT OF METAL WALL STENT AND BIOPSY OF THE AMPULLA, THE SINGLE USE DISTAL COVER FELL OFF OF THE DUODENOVIDEOSCOPE AND WAS RETRIEVED FROM THE PATIENT'S STOMACH. IT WAS NOTICED THAT THE DISTAL COVER WAS NOT ON THE END OF THE ENDOSCOPE AT THE END OF THE PROCEDURE WHEN THE ENDOSCOPE CAME OUT ONTO THE TABLE AND THE TECH BEGAN THE PRECLEANING PROCESS. ANOTHER GASTROINTESTINAL VIDEOSCOPE WAS THEN INSERTED TO RETRIEVE THE FALLEN DISTAL COVER WITH A RETRIEVAL NET. THE PROCEDURE WAS THEN COMPLETED. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THERE WAS NO REPORTED DELAY. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684786 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention BOSTON SCIENTIFIC 13MM SNAREVND M00562690| BS EXTRACTION BALLOON 12-15 M00547010| BS FORCEPSM00513330| BS HYDRA WIREM00556040| BS RETRIEVAL NETDGN-538| BS WALL STENT M00570370LOT # 32000349| COOK SPHINCTEROTOME CT25-MG22537| MAJ-2315 SINGLE USE DISTAL COVER (H2608)