BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19291650 · Received May 10, 2024

    Report

    Report Number
    9610595-2024-09558
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 25, 2024
    Report Date
    July 29, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170452024
    PMA / PMN Number
    K220587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 ADDITIONAL INFORMATION RECEIVED (H11). 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. - THE SUBJECT DISTAL COVER WAS NOT ATTACHED ON THE DEVICE FIRMLY. - STRESS WAS APPLIED TO THE SUBJECT DISTAL COVER DURING THE INTENDED PROCEDURE, SUCH AS FRICTION BY TWISTING AND/OR PUSHING/PULLING THE DEVICE IN THE PATIENT¿S BODY CAVITY, AND INTERFERENCE WITH MOUTHPIECE, ETC. 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 ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE PROVIDER/USER FOLLOWED THE INSTRUCTIONS FOR USE (IFU) ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    E1/ESTABLISHMENT NAME: (B)(6) ACTING FOR & ON BEHALF ADDED HERE DUE TO CHARACTER LIMITATION IN RESPECTIVE FIELD. 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 LINKED PATIENT IDENTIFIER:(B)(6). THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-00253.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD), UPPER GASTROINTESTINAL (GI) ULTRASOUND (US), AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE THE DISTAL COVER FELL OFF OF THE DUODENOVIDEOSCOPE. IT WAS REPORTED THAT THE COVER FELL INTO THE ESOPHAGUS AND PUNCTURED THE ENDOTRACHEAL (ET) TUBE, BUT NO SOFT TISSUE WAS PUNCTURED. THE COVER WAS RETRIEVED WITH GRASPERS. THE RETRIEVAL TIME TOOK LESS THAN 5 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE EVENT OCCURRED WHEN THE PHYSICIAN WAS FINISHING THE PROCEDURE, THEREFORE NO INTERVENTION WAS DONE FOR THE PUNCTURED ET TUBE AND IT WAS REMOVED FOR THE PATIENT'S EMERGENCE FROM ANESTHESIA. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970438 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170452024

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention MAJ-2315 (LOT # H2131)