BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO CF CAPSULE

    MDR report key: 23512043 · Received November 10, 2025

    Report

    Report Number
    MW5178702
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 5, 2025
    Manufacturer
    GIVEN IMAGING LTD./GIVEN IMAGING INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT WAS HERE FOR EGD WITH BRAVO PLACEMENT. BRAVO CAPSULE DID NOT RELEASE FROM GUIDEWIRE DURING PLACEMENT (WAS STILL ATTACHED WHEN REMOVED FROM PT AND NOT PLACED IN ESOPHAGUS AS IT WAS SUPPOSED TO BE). NO HARM TO PT. ANOTHER CAPSULE WAS USED INSTEAD AND DEPLOYED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934543 BRAVO CF CAPSULE ELECTRODE, PH, STOMACH FFT GIVEN IMAGING LTD./GIVEN IMAGING INC. FGS-0636 67110F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention