BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT INJECTION THERAPY NEEDLE

    MDR report key: 1230733 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05538
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIFTH OF FIVE REPORTED MALFUNCTIONS, WHICH OCCURRED DURING THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT PRIOR TO INSERTING AN INTERJECT THERAPY NEEDLE INTO THE GASTROSCOPE, THE NEEDLE FAILED TO EXTEND AND RETRACT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE; THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." REFER TO MFR REPORT #S: 3005099803-2008-05534, 3005099803-2008-05535, 3005099803-2008-05536, AND 3005099803-2008-05537 FOR DETAILS REGARDING THE OTHER FOUR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERJECT INJECTION THERAPY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M00518251 11846713

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK