BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGITRON FFPF EMC

    MDR report key: 1545660 · Received November 24, 2009

    Report

    Report Number
    2428235-2009-00004
    Event Type
    Death
    Date Received
    November 24, 2009
    Date of Event
    February 20, 2007
    Report Date
    November 3, 2009
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K972072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ELLMAN WAS INFORMED OF THIS EVENT BY A REFERENCE MADE TO IT IN A NOV 3, 2009, EMAIL RESPONDING TO AN INQUIRY FOR MORE INFO ON AN EARLIER REPORTED INCIDENT. ELLMAN'S UNDERSTANDING IS THAT THE TREATING PHYSICIAN USED A TECHNIQUE THAT HE DEVELOPED HIMSELF THAT DIFFERS FROM THE MOST SIMILAR DOCUMENTED TECHNIQUE IN THE FOLLOWING MANNERS: THE TECHNIQUE USED MORE THAN TWICE THE POWER; 8 IN CUT/COAG (APPROX 70W AT NOMINAL LOAD) VS THE RECOMMENDED 6 IN FULGURATE (APPROX 30W AT NOMINAL LOAD). SIXTY PERCENT OF THE TONSIL WAS REMOVED COMPARED TO THE RECOMMENDED 50%. THE TISSUE WAS REMOVED IN A SINGLE SESSION VS THE RECOMMENDED THREE SESSIONS. THE ELECTRODE WAS EMBEDDED IN THE TISSUE WHILE ACTIVATED VS SHAVING OFF LAYERS AT THE SURFACE. ALL OF THESE VARIATIONS WOULD PROVIDE GREATER HEAT BUILDUP IN THE SURROUNDING TISSUE. ADDITIONALLY, EMBEDDING THE ELECTRODE IN THE TISSUE WOULD FURTHER REDUCE THE PHYSICIAN'S VISUALIZATION OF THE TISSUE DAMAGE. ELLMAN HAS REQUESTED THE RETURN OF THE PRODUCT FOR TESTING, HOWEVER, THE CURRENT INFO INDICATES THIS INCIDENT IS TECHNIQUE RELATED BASED UPON A PHYSICIAN DEVELOPING HIS OWN PROCEDURAL TECHNIQUE WITH A BASIC SURGICAL ELECTRODE SET.

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED A TONSILLOTOMY USING THE SURGITRON FFPF EMC GENERATOR WITH A TD9B 3MM BALL ELECTRODE TO ABLATE TONSIL TISSUE. THE PHYSICIAN ACTUALLY IMBEDDED THE ELECTRODE INTO THE TISSUE TO ABLATE RATHER THAN KEEPING THE ELECTRODE ON THE SURFACE OF THE TONSIL. POWER SETTINGS WERE 8 IN CUT/COAG WAVE FORM. THE TREATMENT WAS COMPLETED IN A SINGLE SESSION. SEVERAL DAYS FOLLOWING THE SURGERY, THE PT DIED AFTER UNCONTROLLABLE BLEEDING. NO AUTOPSY WAS PERFORMED AND AS A RESULT, THE PHYSICIAN HAS NO ADD'L INFO. THE PHYSICIAN THOUGHT THE BLEEDING COULD HAVE BEEN CAUSED BY INSERTION OF THE ELECTRODE INTO THE TISSUE, LEADING TO DEEPER NECROSIS THAN HAD HE BEEN WORKING AT THE SURFACE OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON FFPF EMC GEI ELLMAN INTERNATIONAL, INC. EMC220

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death