BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OASIS STENT INTRODUCER

    MDR report key: 16953639 · Received May 17, 2023

    Report

    Report Number
    MW5117642
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    May 5, 2023
    Report Date
    May 15, 2023
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE PIECE (COOK FUSION OASIS STENT INTRODUCER) BROKE OFF AND RETAINED IN PATIENT DURING ERCP PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650575 FUSION OASIS STENT INTRODUCER STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COOK MEDICAL LLC C1984789

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female