BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM

    MDR report key: 11937970 · Received June 4, 2021

    Report

    Report Number
    11937970
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 1, 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

    WHILE PURGING THE IMAGING PROBE, THE PROBE FAILED TO PROPERLY PURGE WITHIN THE TUBE, AND SYRINGE FLUID WAS LEAKING THROUGH THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837691 ENDOFLIP MEASUREMENT CATHETER FOR USE WITH ENDOFLIP SYSTEM SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LIMITED EF-325N 2010983JZ

    Patients

    Seq Age Sex Outcome Treatment
    1