BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRODE

    MDR report key: 809629 · Received January 23, 2007

    Report

    Report Number
    1530493-2007-00002
    Event Type
    Other
    Date Received
    January 23, 2007
    Date of Event
    April 13, 2006
    Report Date
    January 22, 2007
    Manufacturer
    OLSEN MEDICAL
    Product Code
    FAS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN THE EVENTS, THIS INCIDENT OCCURRED AS A RESULT OF OPERATOR/END-USER ERROR. THE USER FACILITY ACKNOWLEDGE THIS WAS NOT A MANUFACTURER DEFECT.

    Description of Event or Problem · 1

    THE SURGERY CENTER SENT IN THIS REPORT TO FDA ON 4/18/06 WITH THE FOLLOWING STATEMENT. "A BOVIE WAS USED TO MAKE AN INCISION ABOUT THE CIRCUMFERENCE OF THE TONSIL. DURING THE INCISION, A BURN WAS NOTED IN THE R LATERAL COMMISSURE. EXAMINE WITH THE BOVIE HANDPIECE REVEALED VIOLATION OF THE INSULATION OF THE BOVIE TIP". THIS REPORT WAS SENT TO THE FDA ON THE ABOVE NOTED DATE BY THE SURGERY CENTER. WE RECEIVED THIS DEVICE ON 5/12/2006. THERE WERE MANY VISIBLE SCARS THROUGH THE INSULATION. THE SURGERY CENTER ACKNOWLEDGE THAT THEY USED ANOTHER INSTRUMENT ON THIS DEVICE AND THEY CAUSE THE BREACH IN THE INSULATION. THIS IS DOCUMENTED IN OUR COMPLAINT FILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE ELECTRODE FAS OLSEN MEDICAL 66703 113741

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other