BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DUODENOSCOPE ED-580XT

    MDR report key: 12281593 · Received August 5, 2021

    Report

    Report Number
    1000513161-2021-00007
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    April 30, 2021
    Report Date
    August 5, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    14547410359296
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 07/21/2021, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. WAS INFORMED THAT A PATIENT DEVELOPED PSEUDOMONAS AERUGINOISA BACTERAEMIA WITHIN 3 DAYS AFTER HIS ERCP PROCEDURE HELD (B)(6) 2021. THE FACILITY GOT THE TYPING RESULTS BACK ON JUNE 17, 2021 AND THEY SHOW THAT THE STRAIN FROM THE PATIENT MATCHES THE ONE ISOLATED FROM THE SCOPE. THEY SHARE THE SAME VNTR PROFILE. THE SCOPE HAS BEEN REPROCESSED SEVERAL TIMES SINCE USE ON THIS PATIENT BUT NOT USED ON ANY OTHER PATIENTS. THERE WAS NO DEATH OR OTHER SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181520 FUJIFILM DUODENOSCOPE ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT 14547410359296

    Patients

    Seq Age Sex Outcome Treatment
    1