BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE INSUL. COATED BLADE

    MDR report key: 1160705 · Received August 29, 2008

    Report

    Report Number
    1717344-2008-00409
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 11, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE INCIDENT DEVICE, IT WAS FOUND THAT THE HEX ON THE ELECTRODE WAS NOT PROPERLY LOCKED INTO THE NOSE OF THE PENCIL. THE ELECTRODE WAS THEN SEATED PROPERLY IN THE PENCIL AND PASSED HIPOT TESTING. IF THE ELECTRODE WAS NOT SEATED COMPLETELY BY THE CUSTOMER, THE SAMPLE WOULD HAVE FAILED HIPOT TESTING. THE ELECTRODE AND PENCIL FUNCTIONED NORMALLY WHEN ACTIVATED ON A GENERATOR. ALL TESTS WERE WITHIN SPECIFICATION. THE DEVICE IFU STATES THE ELECTRODE MUST FIT COMPLETELY AND SECURELY INTO THE PENCIL. AN INCORRECTLY SEATED ELECTRODE MAY RESULT IN BURNS TO THE PATIENT OR SURGICAL PERSONNEL. A SAFETY SLEEVE ELECTRODE, IS ALSO AVAILABLE WHICH IS DESIGNED TO HELP PREVENT ALTERNATIVE SITE BURNS DUE TO IMPROPER ELECTRODE INSERTION.

    Description of Event or Problem · 1

    THE REPORT STATES THAT DURING TONSILLECTOMY AND ADENOIDECTOMY, THE ELECTRODE LOOSENED IN THE PENCIL. NO ARCING WAS SEEN BUT A CHILD SUSTAINED A BURN ON THE CORNER OF THE MOUTH. THE BURN WAS DESCRIBED AS A DEEP BURN WITH TREATMENT OF ROOM TEMPERATURE SALINE RINSE AND BACITRACIN OINTMENT, PERFORMED IN THE OR. PARENTS WERE REFERRED TO A PLASTIC SURGEON AFTER AN EXAMINATION 1 1/2 HOURS POST OP. CROW-DAVIS MOUTH GAG USED. O2 AT 50%, 4 LITER FLOW. AFTER THE INCIDENT, THE GENERATOR AND PENCIL WERE TESTED BY THE SITE BIOMEDICAL ENGINEERING DEPARTMENT AND BOTH WERE FOUND TO BE OPERATING NORMALLY. NO PROBLEMS WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE INSUL. COATED BLADE ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR