BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 1081386 · Received July 10, 2008

    Report

    Report Number
    1081386
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    May 14, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    AN EGD WAS SCHEDULED AND DURING THE PROCEDURE, THE INJECTION GOLD PROBE(CAUTERIZATION & SCLEROTHERAPY NEEDLE) WAS NOT FUNCTIONING PROPERLY. THE PROCEDURE WAS STOPPED DUE TO PATIENT DISCOMFORT AND INABILITY TO STOP BLEEDING WITH EQUIPMENT. THE PATIENT WAS GIVEN BLOOD AND RESCHEDULED FOR A LATER TIME WITH MAC. ANOTHER ENDOSCOPE (THERAPEUTIC) WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE DEFECTIVE EQUIPMENT WAS REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE CATHETER, ENDOSCOPIC, HEMOSTASIS KNS BOSTON SCIENTIFIC CORP. * 11445775 AND 11408300

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR