BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP

    MDR report key: 12280321 · Received August 5, 2021

    Report

    Report Number
    12280321
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 22, 2021
    Report Date
    July 26, 2021
    Manufacturer
    CROSPON LIMITED
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER AND SYRINGE WERE PLUGGED INTO THE ENDOFLIP MACHINE TO MAKE SURE IT WAS WORKING CORRECTLY AND AS THE MACHINE WAS DOING ITS CHECKS IT CAME UP AN ERROR SAYING THERE WAS SOMETHING WRONG WITH THE CATHETER. REMOVED THE NON FUNCTIONING CATHETER. NO INJURY OR POTENTIAL INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180840 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LIMITED EF-325N 20E0587JZ

    Patients

    Seq Age Sex Outcome Treatment
    1