BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL ACTIVE CORD

    MDR report key: 506020 · Received January 12, 2004

    Report

    Report Number
    1037905-2004-00006
    Event Type
    Injury
    Date Received
    January 12, 2004
    Date of Event
    November 14, 2003
    Report Date
    December 12, 2003
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    FFZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN USED A WILSON-COOK UNIVERSAL ACTIVE CORD WITH A COMPETITIVE SNARE AND A ELECTROCAUTERY UNIT DURING A COLONOSCOPY AND POLYPECTOMY PRODEDURE. WHEN THE PHYSICIAN APPLIED CURRENT TO THE SNARE THE SNARE DID NOT CONDUCT CURRENT CAUSING THE POLYP TO BE CUT INSTEAD OF CAUTERIZED. THE PHYSICIAN ATTEMPTED TO USE A BICAP PROBE WITH THE SAME ELECTROCAUTERY UNIT AND THE BICAP PROBE DID NOT CONDUCT CURRENT. THE WILSON-COOK UNIVERSAL ACTIVE CORD WAS NOT REQUIRED FOR USE OF THE BICAP PROBE. A SECOND ELECTROCAUTERY UNIT WAS USED, AND THE BICAP WAS THEN SUCCESSFUL. THE PT WAS INJECTED WITH EPINEPHRINE AND THE BLEEDING STOPPED. THE PT WAS HOSPITALIZED AND GIVEN THREE UNITS OF BLOOD. POST PROCEDURE THE PT'S CONDITION WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL ACTIVE CORD MISCELLANEOUS FFZ WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R