BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 3190506 · Received June 21, 2013

    Report

    Report Number
    9710107-2013-00158
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    DURING THE FIRST TWO ATTEMPTS TO PLACE THE CAPSULE ONTO THE PATIENT'S ESOPHAGUS, THE DEVICE TIP STARTED ENTERING THE TRACHEA. THE CAPSULES WERE RETRIEVED. THE THIRD ATTEMPT WAS SUCCESSFUL AND THE CAPSULE WAS PLACED WITHOUT INCIDENT. INTERVENTION WAS NOT REQUIRED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT OR PROCEDURE ITSELF THAT MAY HAVE LED TO THIS EVENT. AN ENDOSCOPY WAS PERFORMED PRIOR TO THE PROCEDURE AND THE ESOPHAGUS APPEARED TO BE NORMAL. THE DEVICE OPERATOR HAS BEEN PERFORMING THIS PROCEDURE FOR APPROXIMATELY FIVE YEARS. LUBRICANT WAS NOT USED TO FACILITATE CAPSULE PLACEMENT. NO KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284061 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. FGS-0313

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention