BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE

    MDR report key: 7005754 · Received November 7, 2017

    Report

    Report Number
    7005754
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    June 14, 2017
    Report Date
    October 19, 2017
    Manufacturer
    GIVEN IMAGING INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    FIRST BRAVO CAPSULE FAILED TO DEPLOY AND ADHERE TO PT'S ESOPHAGUS DURING PROCEDURE, LIKELY DUE TO INADEQUATE SUCTION. A SECOND CAPSULE NEEDED TO BE PREPARED AND CALIBRATED. THIS SECOND CAPSULE DEPLOYED PROPERLY. DISPOSABLE DEVICE MALFUNCTIONED. PROCEDURE CONTINUED WITH ANOTHER DEVICE. TECHNICAL ERROR. THE MAKE OF THE EQUIPMENT THAT FAILED IS: GIVEN IMAGING BRAVO PH CAPSULE DELIVERY DEVICE. REF # FGS-0312; ID # PHZ- BRAVO 100. THE ACTUAL DEVICE WAS DISCARDED RECENTLY. THEY DID KEEP IT WITH THE EXPECTATION THAT IT WOULD BE NEEDED BY RISK BUT AFTER 2 MONTHS OF NOT HEARING ANYTHING THEY EVENTUALLY DISCARDED IT. THEREFORE I DO NOT HAVE THE LOT # OR ID # FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    FIRST BRAVO CAPSULE FAILED TO DEPLOY AND ADHERE TO PT'S ESOPHAGUS DURING PROCEDURE, LIKELY DUE TO INADEQUATE SUCTION. A SECOND CAPSULE NEEDED TO BE PREPARED AND CALIBRATED. THIS SECOND CAPSULE DEPLOYED PROPERLY. DISPOSABLE DEVICE MALFUNCTIONED. PROCEDURE CONTINUED WITH ANOTHER DEVICE. TECHNICAL ERROR. THE MAKE OF THE EQUIPMENT THAT FAILED IS: GIVEN IMAGING BRAVO PH CAPSULE DELIVERY DEVICE. REF # FGS-0312; ID # PHZ- BRAVO 100. THE ACTUAL DEVICE WAS DISCARDED RECENTLY. THEY DID KEEP IT WITH THE EXPECTATION THAT IT WOULD BE NEEDED BY RISK BUT AFTER 2 MONTHS OF NOT HEARING ANYTHING THEY EVENTUALLY DISCARDED IT. THEREFORE I DO NOT HAVE THE LOT # OR ID # FOR THE DEVICE IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787156 BRAVO PH CAPSULE ELECTRODE, PH, STOMACH FFT GIVEN IMAGING INC. FGS-0312

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR