BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED

    MDR report key: 1020577 · Received March 28, 2008

    Report

    Report Number
    1720159-2008-00008
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 5, 2007
    Report Date
    February 27, 2008
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS CURRENTLY IN LITIGATION. FURTHER DETAILED INFORMATION HAS NOT BEEN RELEASED TO CONMED ELECTROSURGERY. IT IS UNCLEAR IF THE SUSPECT DEVICE IS AVAILABLE FOR EVALUATION. CONMED ELECTROSURGERY WILL CONTINUE EFFORTS TO OBTAIN THE SUSPECT DEVICE USED DURING THE PROCEDURE. ADDITIONAL INFORMATION OBTAINED REGARDING THIS REPORT WILL BE REPORTED TO THE FDA OFFICE.

    Description of Event or Problem · 1

    ON 2007, PATIENT WAS TO HAVE A BILATERAL MYRINGOTOMY AND TUBE AND ADENOTONSILLECTOMY. DURING THIS PROCEDURE THE PATIENT WAS SEVERELY BURNED BY THE CAUTERIZING INSTRUMENT ALONG THE EDGE OF THE PATIENT'S MOUTH. THE PHYSICIAN'S MEDICAL RECORDS INDICATE THAT THE CAUTERY WAS WORKING SPORADICALLY AND AFTER SEVERE ATTEMPTS, IT WAS NOTED THAT THERE WAS A FULL THICKNESS BURN OF THE RIGHT ANTERIOR COMMISSURE SECONDARY TO THE TIP NOT BEING SEATED PROPERLY. THIS ACCIDENT AND ENSUING INJURIES HAS CAUSED SEVERE PAIN AND SUFFERING TO THE PATIENT, ALONG WITH PERMANENT DISFIGUREMENT AND/OR SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED PENCIL, BUTTON, W/HOLE. DISP GEI CONMED ELECTROSURGERY 130309 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Other