BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 2250822 · Received September 6, 2011

    Report

    Report Number
    2250822
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 6, 2011
    Manufacturer
    GIVEN IMAGING
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT ESPHOGASTRODUODENOSCOPY (EGD) WITH BIOPSIES. DURING THE PROCEDURE, THE BRAVO CAPSULE FAILED TO DEPLOY AS INTENDED TWICE. BIOPSIES WERE COLLECTED PRIOR TO THIS FAILURE. THE CAPSULE PLACEMENT PORTION OF THE PROCEDURE WAS ABORTED. THE PT WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION AND LATER DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO BRAVO CAPSULE DELIVERY SYSTEM FFT GIVEN IMAGING * 2011-06/15787Q-

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR