BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED

    MDR report key: 836730 · Received April 11, 2007

    Report

    Report Number
    1720159-2007-00018
    Event Type
    Other
    Date Received
    April 11, 2007
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED REC'D ONE (1) 131309 WITH NEEDLE ELECTRODE IN GOOD CONDITION, NO CABLE DAMAGE VISIBLE. WE PERFORMED ESU INTERFACE IN ALL MODES AND THE RETURNED PENCIL PASSED. THE RETURNED PENCIL OPERATED WITHIN SPECIFICATIONS. THE INSTRUCTIONS FOR USE (IFU) STATES: "CONTRAINDICATIONS: THESE DEVICES SHOULD NEVER BE USED WHEN: IN THE PRESENCE OF FLAMMABLE GASES, FLAMMABLE PREP SOLUTIONS OR DRAPES, OXIDIZING GASES SUCH AS NITROUS OXIDE (N2O), OR IN OXYGEN-ENRICHED ENVIRONMENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ESP-BUTTON, W/HOLST&ULTRACLEAN GEI CONMED ELECTROSURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1