BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE INSULATED COATED BLADE

    MDR report key: 4790443 · Received May 19, 2015

    Report

    Report Number
    4790443
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 19, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BOVIE INSULATED TIP WAS NOTED TO BE CRACKED BEFORE IT WAS USED FOR PROCEDURE (WAS ALREADY ON STERILE FIELD). THE TIP WAS IMMEDIATELY REMOVED AND EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324120 EDGE INSULATED COATED BLADE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP E1455 50120061X

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES
    2 *