BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM

    MDR report key: 12180093 · Received July 16, 2021

    Report

    Report Number
    12180093
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 13, 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

    PURGING FAILED AND CATHETER COULD NOT BE USED. THE CATHETER WAS THEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079469 ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LIMITED EF-325N 20E0587JZ

    Patients

    Seq Age Sex Outcome Treatment
    1