BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1191159 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04914
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING AN UPPER GI PROCEDURE, IN WHICH AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS BEING USED, THE NEEDLE WOULD NOT COME OUT OF THE PROBE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 11403548

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK