BEUDAMED
    FDA Adverse Event Other Summary report: N

    INJECTION GOLD PROBE

    MDR report key: 510157 · Received February 6, 2004

    Report

    Report Number
    510157
    Event Type
    Other
    Date Received
    February 6, 2004
    Date of Event
    November 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT WAS HAVING AN EMERGENT UPPER ENDOSCOPY PERFORMED AT THE BEDSIDE FOR A SUSPECTED GASTRIC BLEED. WHILE PERFORMING SCLERAL THERAPY AND COAGULATION, APPROX ONE INCH OF THE CATHETER TIP (PROBE) BROKE OFF IN THE PT'S STOMACH. THE NURSE STATED THAT DUE TO THE ACTUAL BLEEDING FOUND, THEY WERE UNABLE TO NOTE WHETHER THE TIP OF THE GOLD PROBE WAS SUCTIONED OUT THROUGH THE SCOPE. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE BIPOLAR HEMOSTASIS CATHETER KNS BOSTON SCIENTIFIC CORP M00560150 6005908

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other