BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ACTIVE CORD

    MDR report key: 492245 · Received October 27, 2003

    Report

    Report Number
    1037905-2003-00154
    Event Type
    Malfunction
    Date Received
    October 27, 2003
    Date of Event
    September 25, 2003
    Report Date
    September 26, 2003
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, THE PHYSICIAN USED A POLYPECTOMY SNARE WITH A WILSON-COOK UNIVERSAL ACTIVE CORD. WHEN CAUTERY WAS APPLIED, THE USER OBSERVED SPARKS BETWEEN THE SNARE HANDLE AND THE UNIVERSAL ACTIVE CORD. STATIC AND INTERFERENCE WERE OBSERVED ON THE MONITOR DISPLAY. THE MEDICAL STAFF IMMEDIATELY STOPPED ELECTROSURGICAL CURRENT AND REMOVED THE ACTIVE CORD. NO PT OR OPERATOR INJURY WAS REPORTED.

    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