BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSUGICAL GENERATOR

    MDR report key: 2011537 · Received March 3, 2011

    Report

    Report Number
    2011537
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    October 11, 2010
    Report Date
    March 3, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    DURING AN AORTIC VALVE REPLACEMENT, THE SURGEON WAS OPENING THE PATIENT'S CHEST AND USED BOVIE TO OBTAIN HEMOSTASIS. A RAY-TEC SPONGE WAS IN PATIENT'S CHEST. SURGEON FELT HEAT ON HIS RIGHT HAND AND CHECKED THE GLOVE FOR PERFORATION AND FOUND NONE. SCRUB TECH NOTED RAY-TEC SPONGE WAS SMOLDERING AND QUICKLY REMOVED IT FROM THE WOUND. WHEN SPONGE HIT THE AIR, IT IGNITED. SPONGE WAS THROWN ON FLOOR AND EXTINGUISHED WITH COLD SALINE. GROUNDING PADS FOR BOVIE WERE PLACED UNDER PAD FOR KIMBERLY CLARK WARMING UNIT. IT IS POSSIBLE PATIENT WAS NOT PROPERLY GROUNDED DUE TO MULTIPLE PADS BEING USED. NO HARM TO PATIENT. PROCEDURE CONTINUED WITHOUT FURTHER DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSUGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN VALLEYLAB F2G18771T *
    2 * ELECTROSURGICAL PENCIL GEI COVIDIEN VALLEYLAB E2514H 188174
    3 PATIENT RETURN ELECTRODE RETURN PAD GEI COVIDIEN VALLEYLAB E750 189956

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR