BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTS

    MDR report key: 2880869 · Received December 14, 2012

    Report

    Report Number
    2880869
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REQUESTED THE PATIENT CARE TECHNICIAN FLEX THE BOW UP SEVERAL TIMES IN AN EFFORT TO GET THE PROPER POSITION. THE BOW SNAPPED. THE PROCEDURE WAS COMPLETED AND THE RESULT WAS A SUCCESSFUL CANNULATION OF PATIENT WITH STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTS SPHYNCTEROSCOPE FDR COOK MEDICAL * W3167717

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR