BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 19201293 · Received April 29, 2024

    Report

    Report Number
    2429304-2024-00233
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 29, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170405563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED, DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR A STONE IN THE DUCT, THE SINGLE USE DISTAL COVER BROKE OFF THE DUODENOVIDEOSCOPE AND FELL INSIDE THE PATIENT. THE BOTTOM PORTION OF THE CAP BROKE CAUSING IT TO FALL INSIDE THE PATIENT. AFTER THE SCOPE WAS PULLED OUT OF THE PATIENT, THE TECH NOTICED THE CAP WAS NOT ON THE END AND NOTIFIED THE DOCTOR, WHO WENT BACK DOWN THE ESOPHAGUS WITH AN ESOPHAGOGASTRODUODENOSCOPY (EGD) TO FIND THE CAP. THE CAP WAS FOUND INSIDE THE PATIENTS STOMACH AND A BIOPSY FORCEPS WAS USED TO REMOVE THE CAP. THE PROCEDURE WAS COMPLETED AND THERE WAS NO NOTED PATIENT HARM. THE DEVICE WAS INSPECTED BEFORE USE BY TWO TECHNICIANS AND THE CAP WAS VERIFIED TO BE PUT ON PROPERLY. THIS MEDWATCH IS RELATED TO PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979404 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V 04953170405563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SINGLE USE DISTAL COVER MAJ-2315 / H3308