BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ BIOPSY VALVE

    MDR report key: 15464069 · Received September 22, 2022

    Report

    Report Number
    1000513161-2022-00013
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    July 20, 2022
    Report Date
    September 21, 2022
    Manufacturer
    FUJIFILM MEDWORK GMBH
    Product Code
    ODC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON JULY 20, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING JAZZ BIOPSY VALVE. DURING A DIAGNOSTIC PROCEDURE, PART OF THE VALVE WAS FOUND IN THE PATIENT'S STOMACH AFTER THE FORCEPS WERE INTRODUCED THROUGH THE VALVE. THE PART WAS RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO DEATH REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636022 JAZZ BIOPSY VALVE ENDOSCOPE CHANNEL ACCESSORY ODC FUJIFILM MEDWORK GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention