BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON RADIOLASE

    MDR report key: 1211045 · Received October 24, 2008

    Report

    Report Number
    2428235-2008-00006
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K992382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADIOLASE 1 GENERATOR WAS RETURNED FOR TESTING. TO DATE, THE ELECTRODE(S) HAVE NOT BEEN RETURNED. THE GENERATOR WAS TESTED AND FOUND TO BE IN PROPER WORKING ORDER. THE INSTRUCTIONS FOR USE THAT ARE PROVIDED WITH EACH ELECTRODE STATE THAT THE POWER SETTING FOR MATRIXECTOMIES IS BETWEEN 2-3 AND THE RECOMMENDED TREATMENT TIME IS APPROXIMATELY 2-4 SECONDS. THE INSTRUCTIONS FOR USE ARE PROVIDED WITH EACH ELECTRODE. THE PHYSICIAN WAS UTILIZING TOO MUCH POWER (SETTING OF 5) FOR TOO LONG A TIME PERIOD (15 SECONDS). THE CAUSE OF THE INJURY WAS BOTH TOO MUCH POWER AND TOO LONG OF A TREATMENT TIME. WE HAVE REQUESTED RETURN OF THE ELECTRODES, BUT TO DATE HAVE NOT RECEIVED THEM. WE HAVE DETERMINED THAT THE INJURY DID NOT OCCUR AS A RESULT OF DEVICE FAILURE.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT MATRIXECTOMIES ON 4 TOES. THE GENERATOR WAS SET TO A DIAL SETTING OF 5. A 3% MEPIVACAINE HYDROCHLORIDE ANAESTHETIC WAS USED TO NUMB THE TOES - 2 LARGE TOES AND 2 MIDDLE TOES. THE FIRST TOE NAIL WAS REMOVED WITHOUT INCIDENT. AS SOON AS THE MATRIXECTOMY PROBE TOUCHED THE NAIL BED ON THE FIRST LESSER TOE, THE PATIENT SCREAMED OUT. THE SETTING WAS REDUCED TO 4 AND THE PROCEDURE WAS THEN TOLERABLE. HOWEVER, FOR EACH OF THE REMAINING TOES THE INTENSITY WAS PUT UP TO 5, THE PATIENT WAS AWARE OF DISCOMFORT WHEN THE PROBE TOUCHED THE SKIN, BUT TOLERATED THE HEAT. TO ABLATE THE NAIL BED, THE WIDE PROBE WAS USED, LIGHTLY SWEEPING THE NAIL BED PROXIMAL TO DISTAL AND THEN LEFT TO RIGHT AT THE BASE. THE WHOLE PROCESS TOOK NO LONGER THAN 15 SECONDS ON THE LARGE TOES. THE PATIENT REPORTS HER TOES BURNING FOR THE NEXT DAY WHEN SHE RETURNED TO CLINIC. A WEEK LATER, THE LARGE TOE ON THE LEFT HAD A SUNKEN APPEARANCE - THE NAIL BED WAS CONCAVE, VERY INFLAMED AND VERY PAINFUL. THIS WAS NOT THE TOE THAT CAUSED THE PATIENT PAIN. THE TOE WAS DRESSED AND SWABBED AND ANTIBIOTICS WERE PRESCRIBED. THE NAIL BED WENT ON TO ULCERATE, EXPOSING THE DISTAL PHALANX. THE LESSER TOES ARE NOW ALMOST HEALED AND THE RIGHT GREAT TOE IS HEALING. THE LEFT TOE IS NOW SHOWING SIGNS OF GRANULATING. THE RL1 GENERATOR WAS USED ON FOUR ADDITIONAL PATIENTS OVER A 2 WEEK PERIOD. A SECOND PATIENT COMPLAINED OF A BURNING SENSATION. THERE WAS NO INJURY ON FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITRON RADIOLASE GEI ELLMAN INTERNATIONAL, INC. RADIOLASE I

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization