BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 3915235 · Received May 22, 2014

    Report

    Report Number
    9710107-2014-00114
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    IVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE DELIVERY SYSTEM WAS NOT BENT BUT THE PLUNGER WAS BROKEN. THE PLUNGER ROTATED MORE THAN 1/8 OF A TURN. 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 OTHER VISIBLE DAMAGE. AS THE PRODUCT WAS RECEIVED, THE PLUNGER ROTATING MORE THAN 1/8 OF A TURN 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 DEVICE OPERATOR HAS BEEN PERFORMING THIS PROCEDURE FOR OVER FIVE YEARS. LUBRICANT WAS USED ON THE BACKSIDE OF THE CAPSULE TO FACILITATE CAPSULE PLACEMENT. NO KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306289 BRAVO BRAVO PH CAPSULE FFT IVEN IMAGING LTD. FGS-0313 22583Q

    Patients

    Seq Age Sex Outcome Treatment
    1