BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 3102601 · Received May 1, 2013

    Report

    Report Number
    9710107-2013-00115
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Report Date
    April 10, 2013
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REFERENCE NUMBER: (B)(4). ADDITIONAL INFORMATION (EXPIRATION DATE), (PATIENT CODE, DEVICE CODE, METHOD CODE, RESULTS CODE), THE DEVICE WAS RETURNED TO MEDTRONIC FOR INVESTIGATION. DUE TO THE REPORTED CONDITION AND THE LOT NUMBER OF THE REPORTED AND RETURNED DEVICE, AN INVESTIGATION WAS NOT PERFORMED AS IT IS ADDRESSED IN CORRECTIVE ACTION PREVENTATIVE ACTION (CAPA)# (B)(4) . THE CAPA WAS OPENED TO ADDRESS THE TROCAR PIN/NEEDLE OF THE DELIVERY SYSTEM NOT BEING DEPLOYED AS DESIGNED, WHICH RESULTED TO THE FAILURE OF BRAVO CAPSULE ATTACHING TO THE ESOPHAGEAL MUCOSA. THE CAPA WAS DEEMED EFFECTIVE ON (B)(4) 2012. THIS SUPPLEMENTAL MDR IS BEING FILED LATE AS PART OF A REMEDIATION EFFORT UNDER (B)(4). CORRECTED DATA INFORMATION IN SECTION WAS INCORRECTLY ENTERED DURING THE INITIAL FILING. THERE WAS NO REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE IN THIS CASE. INFORMATION IN SECTION WAS INCORRECTLY ENTERED DURING THE INITIAL FILING. THE INFORMATION WAS UPDATED IN SECTION D OF THIS SUPPLEMENTAL. (MODEL NUMBER), (CONCLUSIONS CODE).

    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 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 OVER A YEAR. NO KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188978 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. FGS-0313 20161Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention