BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DUODENOSCOPE ED-580T

    MDR report key: 21532507 · Received March 5, 2025

    Report

    Report Number
    3001722928-2025-00011
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 6, 2025
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    04547410330649
    PMA / PMN Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE COMMUNICATION ERROR BETWEEN THE PHYSICIAN AND THE CLEANING STAFF, THE PIGTAIL STENT WAS LEFT IN THE ENDOSCOPE'S FORCEPS CHANNEL. SINCE ED-580T IS SIMILAR TO ED-580XT (510(K) NUMBER; K191747) MARKETED IN U.S., FUJIFILM SUBMIT THIS MDR. THE UDI-DI FOR ED-580TX IN THE UNITED STATES IS (B)(4).

    Description of Event or Problem · 0

    DURING AN ERCP USING THE DUODENOSCOPE ED-580T, A FRAGMENT OF A PIGTAIL STENT THAT HAD BEEN REMOVED FROM ANOTHER PATIENT DURING A PREVIOUS DUODENOSCOPY WAS EJECTED FROM THE DUODENOSCOPE. THE PIGTAIL STENT WAS RETRIEVED FROM THE DIGESTIVE TRACT USING THE DUODENOSCOPE. THE PHYSICIAN WAS AWARE THAT THE PIGTAIL STENT HAD TORN INSIDE THE DUODENOSCOPE DURING THE PREVIOUS ERCP. HOWEVER, THE PHYSICIAN DID NOT INFORM THE CLEANING STAFF. THE FACILITY BELIEVES THAT THE RISK OF CROSS-INFECTION IS SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593372 FUJIFILM DUODENOSCOPE ED-580T DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT FUJIFILM CORPORATION ED-580T 04547410330649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention