BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R. WOLFE - CORD

    MDR report key: 1100543 · Received August 5, 2008

    Report

    Report Number
    MW5007889
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 4, 2008
    Manufacturer
    R. WOLFE
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE OPERATING, THE SURGEON NOTED THAT THE CAUTERY HAD QUIT WORKING. WHEN HE INVESTIGATED WHY IT WAS NO LONGER WORKING, IT WAS DISCOVERED THAT THE CORD WAS BURNED IN TWO PIECES. THE CORD WAS NOT IN THE DRAPES. IT WAS OFF THE FIELD AND CLOSER TO THE CAUTERY UNIT RECEPTIBLE. NO INJURY OCCURRED TO PATIENT OR STAFF. THE UNIT TESTED FINE. NO PROBLEMS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R. WOLFE - CORD LAPAROS COPIC MONOPOLAR CORD JOS R. WOLFE 8106.033

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR