BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOFLIP

    MDR report key: 14227316 · Received April 27, 2022

    Report

    Report Number
    3006897778-2022-00001
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    April 7, 2022
    Report Date
    April 27, 2022
    Manufacturer
    CROSPON LTD
    Product Code
    FFX
    UDI-DI
    05391530810012
    PMA / PMN Number
    K160725
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE CATHETER WAS ENTERED INTO THE TRACHEA INSTEAD OF THE ESOPHAGUS. THERE WAS A MINOR BLEEDING. THE CATHETER WAS NEVER FILLED WITH FLUID WHILE INSIDE THE PATIENT. THE PHYSICIAN REALIZED THE LOCATION AND REMOVED THE CATHETER WITHOUT HESI TATION/RESISTANCE. THE STAFF WORKED TO STABILIZE THE PATIENT AND ORDERED CHEST X-RAYS. THE X-RAYS CAME BACK OK AND THE PATIENT WAS CLEARED TO GO HOME. THEY DID NOT MOVE FORWARD WITH THE CASE AND IT WAS CANCELED. THE PATIENT HAD A SUSPECTED SWALLOWING DISORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085508 ENDOFLIP SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX CROSPON LTD EF-322N 05391530810012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention