BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1213843 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05426
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DATE OF THE EVENT IS UNK. (REPORTED TO BE 2008). BOSTON SCIENTIFIC WAS MADE AWARE THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE NEEDLE CATHETER WAS BROKEN BELOW THE HANDLE AND OUTSIDE OF THE PROBE CATHETER. THE CASE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. PT WAS REPORTED TO BE "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 11215313

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK