BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1060786 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00692
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE CODES WERE SELECTED BY THE MFR AS A RESULT OF INFO OBTAINED FROM THE USER FACILITY. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS INFORMED THAT DURING COLONOSCOPY PROCEDURE, THE INJECTION GOLD PROBE BIPOLAR CATHETER DID NOT WORK. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE ANOTHER GOLD PROBE CATHETER WITH NO PATIENT COMPLICATIONS. THE PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560150 11326795

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR