BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 12083263 · Received June 29, 2021

    Report

    Report Number
    12083263
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 24, 2021
    Report Date
    June 25, 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

    SETTING UP THE ENDOFLIP FOR HIATAL HERNIA REPAIR. AFTER ALL STEPS WERE FOLLOWED TO PURGE THE CATHETER AN ERROR MESSAGE WAS RECEIVED. REPEAT TESTING WAS PERFORMED WITH THE CATHETER TEST CONTINUING TO RUN FOR 10 PLUS MINUTES (INSTEAD OF USUAL 3). THE CATHETER AND SYRINGE WERE PLACED IN A BAG, AND A NEW CATHETER AND SYRINGE WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982058 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LIMITED EF-325N 20H1035JZ

    Patients

    Seq Age Sex Outcome Treatment
    1