BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM

    MDR report key: 12727342 · Received November 1, 2021

    Report

    Report Number
    12727342
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 28, 2021
    Report Date
    October 28, 2021
    Manufacturer
    CROSPON LIMITED
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ENDOFLIP SET UP, THE CATHETER AND SYRINGE WERE INSERTED INTO THE MACHINE AND THE PURGE WAS STARTED. ERROR MESSAGE STATED THAT TEST FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630547 ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LIMITED EF-322N 20L0672JZ

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA