BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD PROBE HEMOSTASIS CATHETER

    MDR report key: 1191238 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04830
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K970278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT AVAILABLE FOR THE EVAL, AS IT IS DISPOSED IN THE FACILITY. THE RELATIONSHIP OF THE EVENT AND DEVICE IS UNDETERMINED.

    Description of Event or Problem · 1

    B3: DATE OF THE EVENT IS UNK. DURING THE COLONOSCOPY PROCEDURE, THE PHYSICIAN COULD NOT GET ANY CAUTERY FROM THE GOLD PROVE HEMOSTASIS CATHETER. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT'S CONDITION IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD PROBE HEMOSTASIS CATHETER KNS BOSTON SCIENTIFIC CORPORATION M00560071 11665274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK