BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 4801886 · Received May 26, 2015

    Report

    Report Number
    9710107-2015-00154
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Report Date
    May 21, 2015
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY: ONE CAPSULE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE DELIVERY SYSTEM WAS NOT RETURNED. THE TROCAR NEEDLE WAS ADVANCED. THE CAPSULE ELECTRODES WERE VISUALLY ACCEPTABLE. AS THE PRODUCT WAS RECEIVED, THE DEVICE FUNCTIONED PER SPECIFICATION, HOWEVER A ROOT CAUSE COULD NOT BE DETERMINED WITHOUT THE DELIVERY SYSTEM.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    A REPEAT PROCEDURE WAS PERFORMED. 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 PROCEDURES FOR A FEW MONTHS. 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
    341131 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. BRAVO PH CAPSULE 27231Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention