BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BRAVO PH MONITORING

    MDR report key: 2141413 · Received June 8, 2011

    Report

    Report Number
    2141413
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 22, 2011
    Manufacturer
    GIVEN IMAGING INC
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BRAVO PH PROBE APPLICATION DEVICE WAS ADVANCED INTO THE ESOPHAGUS AND POSITIONED AT 34CM. THE SUCTION DEVICE WAS THEN APPLIED. SUCTION WAS APPLIED FOR A FULL MINUTE AFTER REACHING THE APPROPRIATE PRESSURE. THE APPLICATION DEVICE WAS THEN DEPLOYED. AS THE PHYSICIAN TRIED TO REMOVE THE APPLICATION DEVICE, THEY NOTED RESISTANCE AND ADVANCED THE SCOPE. VISUALIZING THE AREA OF INVOLVEMENT NEAR 34CM, IT WAS NOTED THAT THE APPLICATION DEVICE WAS FREE OF THE PROBE, BUT THE PROBE WAS NOT ON THE ESOPHAGEAL WALL. THE APPLICATION DEVICE WAS THEN WITHDRAWN. THE ENDOSCOPE WAS THEN ADVANCED INTO THE STOMACH AND A BASKET WAS USED TO GRASP THE BRAVO PH CAPSULE. THE SCOPE WAS THEN WITHDRAWN WITH THE BASKET AND THE BRAVO PH CAPSULE ATTACHED. ASSESSMENT OF THE AREA REVEALED SOME ERYTHEMA, BUT NO DEEP TEARS. A SECOND ATTEMPT WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, BRAVO PH MONITORING CATHETER BASED CAPSULE APPLICATOR FFT GIVEN IMAGING INC UNK 14491Q

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR