BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED ULTRACLEAN 1" NEEDLE

    MDR report key: 528214 · Received February 23, 2004

    Report

    Report Number
    1317214-2004-00010
    Event Type
    Other
    Date Received
    February 23, 2004
    Date of Event
    January 19, 2004
    Report Date
    January 19, 2004
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A THYROIDECTOMY PROCEDURE, THE TIP FLAMED AND THE INSULATION BURNED. THE SETTINGS USED WERE 30 CUT AND 30 COAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ULTRACLEAN 1" NEEDLE ACTIVE ACCESSORY ELECTRODE GEI CONMED CORPORATION NA 0310221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other