BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 3190502 · Received June 21, 2013

    Report

    Report Number
    9710107-2013-00155
    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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE DELIVERY SYSTEM WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE CAPSULE WAS NOT RETURNED FOR INVESTIGATION. THE DELIVERY SYSTEM WAS INVESTIGATED VISUALLY FOR EXTERNAL DAMAGE. THE DELIVERY SYSTEM WAS BENT SLIGHTLY AT THE END OF THE HANDLE, BUT THE PLUNGER WAS NOT BROKEN. THE PLUNGER ROTATED MORE THAN 1/8 OF A TURN. THE EMERGENCY RELEASE ON THE DELIVERY SYSTEM WAS NOT IMPLEMENTED. 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 PLUNGER ROTATED MORE THAN 1/8 OF A TURN WHICH IS INDICATIVE OF MISHANDLING. 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 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 SITE HAS BEEN PERFORMING THIS PROCEDURE FOR ABOUT FIVE YEARS. NO KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283819 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. FGS-0313 21057Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention