BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO CF REFLUX CAPSULE DELIVERY

    MDR report key: 23495307 · Received November 6, 2025

    Report

    Report Number
    MW5178564
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 31, 2025
    Manufacturer
    GIVEN IMAGING INC. / GIVEN IMAGING LTD.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT OCCURRED IN ENDOSCOPY FOR AN EGD BRAVO. BRAVO CAPSULE LOT #66652F. ID# (B)(6) CAPSULE PLACEMENT PROTOCOL FOLLOWED. CAPSULE FAILED TO DETACH, CAPSULE WAS REMOVED FROM ESOPHAGUS WITH THE PLACEMENT DEVICE AS IT WAS STILL ATTACHED TO PLACEMENT DEVICE. AFTER THIS THIRD ATTEMPT (3 SEPARATE CAPSULES FROM THE SAME LOT), SURGEON REQUESTED THAT THIS BOX OF LOT#66652F CAPSULE RELEASE DEVICES BE REMOVED. PT CODE: 4582. DEVICE CODES: 2547, 2906. REF REPORTS: MW5178563, MW5178565.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181698 BRAVO CF REFLUX CAPSULE DELIVERY ELECTRODE, PH, STOMACH FFT GIVEN IMAGING INC. / GIVEN IMAGING LTD. 66652F

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention