BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 4801939 · Received May 26, 2015

    Report

    Report Number
    9710107-2015-00124
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Report Date
    May 21, 2015
    Manufacturer
    GIVEN IMAGING LTD., HERMON BUILDING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM AND CAPSULE WERE RETURNED TO MEDTRONIC FOR EVALUATION. THE DELIVERY SYSTEM WAS INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE TROCAR NEEDLE WAS ADVANCED. THERE WERE SIGNS OF BLOOD OR TISSUE ON THE DEVICE. THE DELIVERY SYSTEM WAS NOT BENT AND THE PLUNGER WAS NOT BROKEN. THE EMERGENCY RELEASE ON THE DELIVERY SYSTEM WAS NOT IMPLEMENTED. THE CAPSULE ELECTRODES WERE VISUALLY ACCEPTABLE. THE WIRE THAT HOLDS THE CAPSULE WAS COMPLETELY OFF AND THE FOAM GASKET WAS IN GOOD CONDITION. THE DELIVERY SYSTEM DID NOT HAVE ANY VISIBLE DAMAGE. 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 NOT NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. 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 SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340453 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD., HERMON BUILDING FGS-0313 25453Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention