BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCALPEL ELECTRODE

    MDR report key: 1833781 · Received September 9, 2010

    Report

    Report Number
    2428235-2010-00006
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESCRIPTION OF THE INCIDENT INDICATES THAT THE SCALPEL ELECTRODE WAS INADVERTENTLY PLACED IN CONTACT WITH A METAL ELEVATORIUM WHICH WAS IN CONTACT WITH THE PATIENT. THE ELEVATORIUM THEN PROVIDED AN ELECTRICAL PATH FOR THE BURN. THIS IS A KNOWN RISK OF ELECTROSURGICAL DEVICES. MORE THAN ONE REQUEST WAS MADE TO HAVE THE DEVICE RETURNED TO THE MANUFACTURER, BUT IT WAS NOT. THE USER FACILITY ADVISED THAT THE DEVICE WAS SENT TO A LOCAL SERVICE IN (B)(6), FOR EVALUATION AND TESTING. THEY ADVISED THAT IT WAS DETERMINED THAT THERE WAS NO DEFECT. NO REPORT OR DOCUMENTATION WAS RECEIVED HOWEVER. IT WAS FURTHER STATED BY THE USER FACILITY THAT THEY ATTRIBUTED THE EVENT TO USER ERROR. BASED ON WHAT WE KNOW OF THE EVENT, WE CONCLUDE THE SAME.

    Description of Event or Problem · 1

    DURING A TONSILLOTOMY IN (B)(6), USING THE SCALPEL ELECTRODE, THE PATIENT RECEIVED A BURN IN THE CORNER OF HIS MOUTH ON THE RIGHT SIDE WHEN THE EDGE OF THE ELECTRODE MADE CONTACT WITH THE METAL ELEVATORIUM HELD BY AN ASSISTANT. THE OPPOSITE OF THE ELEVATORIUM RESTED AGAINST THE CORNER OF THE PATIENT'S MOUTH WHICH IS WHERE THE BURN OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCALPEL ELECTRODE GEI ELLMAN INTERNATIONAL, INC. E2B

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention