BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE BIPOLAR CATHETER

    MDR report key: 1060755 · Received June 12, 2008

    Report

    Report Number
    3005099803-2008-00694
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 14, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE COLONOSCOPY PROCEDURE, THE INJECTION GOLD PROBE BIPOLAR CATHETER WOULD NOT BURN. THE PHYSICIAN USED ANOTHER GOLD PROBE TO COMPLETE THE CASE WITH NO COMPLICATIONS TO THE PT. THE PT'S CONDITION WAS REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560160 11353103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK