BEUDAMED
    FDA Adverse Event Other Summary report: N

    MACROLYTE DISPERSIVE ELECTRODE

    MDR report key: 471787 · Received July 15, 2003

    Report

    Report Number
    1317214-2003-00035
    Event Type
    Other
    Date Received
    July 15, 2003
    Date of Event
    June 2, 2003
    Report Date
    June 16, 2003
    Manufacturer
    CONMED CORP.
    Product Code
    JOS
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FLASH FIRE OCCURRED WHILE THE ELECTROSURGICAL UNIT WAS BEING USED TO PREPARE FOR AN ECMO CANNULA INSERTION". THE INFANT CAME IN CRITICAL AND UNSTABLE. AFTER THE PROCEDURE, PT WAS CRITICAL, BUT STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACROLYTE DISPERSIVE ELECTRODE DISPERSIVE ELECTRODE JOS CONMED CORP. NA 0211011

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Other 2) SWITCHING ESP (2003)| 1) EXCALIBUR PLUS ESU (2003)