BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 12287445 · Received August 6, 2021

    Report

    Report Number
    12287445
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 26, 2021
    Report Date
    July 27, 2021
    Manufacturer
    CROSPON LIMITED
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED AFTER SETUP AND GAVE ERROR MESSAGE THAT STATED "YOUR PRECHECK HAS FAILED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186067 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LIMITED EF-325N 20C0100JZ

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA