BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 3190509 · Received June 21, 2013

    Report

    Report Number
    9710107-2013-00150
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 23, 2013
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE CAPSULE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE TROCAR NEEDLE WAS ADVANCED. THERE WERE NO SIGNS OF BLOOD OR TISSUE ON THE DEVICE. THE CAPSULE ELECTRODES WERE VISUALLY ACCEPTABLE. AS THE PRODUCT WAS RECEIVED, THE DEVICE FUNCTIONED PER SPECIFICATION. THERE WAS NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE IN THIS CASE. THE INFORMATION WAS UPDATED IN THIS SUPPLEMENTAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO ATTACH. THE PATIENT WAS NOT INJURED FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPEAT PROCEDURE WAS NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. INTERVENTION WAS NOT REQUIRED. THERE WAS CLEAR MUCUS PRESENT. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE ESOPHAGUS APPEARED TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283529 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. FGS-0313 20973Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention