BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 8935480 · Received August 27, 2019

    Report

    Report Number
    8935480
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 1, 2019
    Manufacturer
    CROSPON LIMITED
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDOFLIP WAS SET UP BY RN IN THE USUAL MANNER. MD PLACED THE CATHETER DOWN PATIENT'S ESOPHAGUS. THE ENDOFLIP SCREEN WAS GIVING AN ODD PRESENTATION OF THE CATHETER SHAPE WHEN INFLATED. WHEN CHECKED AGAIN AT THE END OF THE CASE, THE PROBLEM PERSISTED. MD REMOVED CATHETER FROM PATIENT'S ESOPHAGUS AND IT WAS NOTED THAT THE PLASTIC HAD TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731870 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LIMITED EF-325N

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA