BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES

    MDR report key: 516782 · Received March 19, 2004

    Report

    Report Number
    2430952-2004-00008
    Event Type
    Malfunction
    Date Received
    March 19, 2004
    Report Date
    March 19, 2004
    Manufacturer
    BOWA ELECTRONIC ZUBEHOR FUR ELEKTROCHIRU
    Product Code
    FFZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS BEING USED DURING A SURGICAL PROCEDURE. THE CORD SPLIT DURING USE IN THE O.R. THE CORD "POPPED" APART WITH SPARKS AND SMOKE AT THE CAUTERY END OF THE CORD. THERE WAS NO INDICATION OF ENSUING FIRE OR INJURY TO STAFF OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES ENDOSCOPIC INSTRUMENT FFZ BOWA ELECTRONIC ZUBEHOR FUR ELEKTROCHIRU 600-290 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *