BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAY PROBE INSULATED BLUE WITH SPRING

    MDR report key: 899034 · Received July 19, 2007

    Report

    Report Number
    899034
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    April 3, 2007
    Report Date
    July 18, 2007
    Manufacturer
    MIZUHO AMERICA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING TRANSNASAL TRANSSPHENOIDAL (TNTS) SURGERY, THE PHYSICIAN USED THE BAY PROBE INSULATED BLUE WITH SPRING (BOVIE STICK) INSIDE THE PATIENT'S NOSE. PHYSICIAN NOTED A BURN ON THE PATIENT'S LEFT BASE OF THE NOSE, ABOUT 1 CM. PHYSICIAN INSPECTED THE BAY PROBE INSULATED BLUE WITH SPRING; THERE WERE TWO HOLES IN THE INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAY PROBE INSULATED BLUE WITH SPRING INSTRUMENT SET, TRANSNASAL TRANSSPHENOIDAL GEI MIZUHO AMERICA, INC. ISOLATED BAYONET SPRING 110MM ITEM 07-824-02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *