BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POINTED COAGULATING ELECTRODE

    MDR report key: 1600086 · Received February 2, 2010

    Report

    Report Number
    1600086
    Event Type
    Malfunction
    Date Received
    February 2, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 2, 2010
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD STARTED USING THE POINTED COAGULATING ELECTRODE IN THE PATIENT; WITHIN A FEW MINUTES THE POINT CRACKED OR SPLIT IN HALF. WE THEN REPLACED WITH A NEW ONE AND AFTER A FEW MINUTES THE TIP ON THE NEW ELECTRODE CRACKED IN HALF AS WELL. BOTH DEVICES ARE FROM THE SAME LOT NUMBER. THE POWER LEVEL WAS 160 CUT/80 COAG. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POINTED COAGULATING ELECTRODE POINTED COAGULATING ELECTRODE GEI KARL STORZ ENDOSCOPY AMERICA, INC. * 38328

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR