BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECNOLITH EM1000

    MDR report key: 2858801 · Received November 19, 2012

    Report

    Report Number
    3002807616-2012-00001
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    September 23, 2010
    Report Date
    November 19, 2012
    Manufacturer
    MEDISPEC, LTD.
    Product Code
    LNS
    PMA / PMN Number
    K063504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, A COMPLAINT REPORT FORM DESCRIBING AN ADVERSE EVENT WAS FILLED OUT BY MEDISPEC SERVICE EMPLOYEE. THE ADVERSE EVENT WAS DESCRIBED ON THE CRF AS BRUISING ON PATIENT'S SKIN AT THE END OF THE ESWL PROCEDURE. THIS KIND OF INJURY IS COMMON AMONG ESWL PATIENTS AND IS NOT CONSIDERED A SERIOUS ADVERSE EVENT. AN EVALUATION OF THIS DEVICE WAS CARRIED OUT, FOLLOWING THE COMPLAINT. NO DEVICE MALFUNCTION WAS DETECTED. ON (B)(6) 2012 A PUBLISHED ARTICLE REPORTING THIS CASE WAS BROUGHT TO OUR ATTENTION. IN THIS ARTICLE, THE INJURY OF THE PATIENT IS DESCRIBED AS A SECOND DEGREE BURN, WHICH IS AN UNEXPECTED ADVERSE EVENT FOLLOWING ESWL. AN INVESTIGATION WAS OPENED AND SEVERAL ATTEMPTS WERE MADE TO CONTACT THE TREATING PHYSICIAN, IN ORDER TO ESTABLISH WHETHER THE PATIENT SUFFERED ANY PERMANENT DAMAGE, RESULTING FROM THE TREATMENT. ONLY ON (B)(6) 2012, WE RECEIVED A RESPONSE FROM DR (B)(6), ACCORDING TO WHICH THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT FOR THE BURN AND THAT THE PATIENT HAS PERMANENT SCAR DUE TO THE BURN. MEDISPEC WAS NOT AWARE OF THE SEVERITY OF THE INJURY AND THE PRESENCE OF A PERMANENT DAMAGE BEFORE RECEIVING THIS ARTICLE AND THE ADDITIONAL DATA FROM DR (B)(6). IN ORDER TO INVESTIGATE THE INCIDENT, MEDISPEC DID ALL EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM THE TREATING PHYSICIAN. ONLY AFTER RECEIVING THE ADDITIONAL INFORMATION, MEDISPEC WAS ABLE TO RE-EVALUATE THE SEVERITY OF THE INJURY. IT IS IMPORTANT TO NOTE THAT PATIENTS TREATED WITH THE SAME DEVICE BEFORE AND AFTER THIS INCIDENT DID NOT DEVELOP ANY UNANTICIPATED OR SERIOUS SIDE EFFECTS OR COMPLICATIONS. THE RELATEDNESS OF THE INJURY TO THE DEVICE WAS INVESTIGATED. CLEARLY, THE INITIAL ERYTHEMA IS ATTRIBUTED TO THE ESWL TREATMENT. THIS KIND OF REACTION, THOUGH USUALLY LESS SEVERE, IS COMMONLY SEEN IMMEDIATELY AFTER ESWL TREATMENT. SUCH ERYTHEMAS USUALLY RESOLVE SPONTANEOUSLY WITH TIME. IN THIS CASE, THE DETERIORATION IN THE PATIENT'S CONDITION OCCURRED ONLY AFTER HE WAS RELEASED FROM THE HOSPITAL. BLISTERS RESULTING FROM A BURN OCCUR IMMEDIATELY AFTER THE BURN EVENT, WHILE BLISTERS RESULTING FROM FRICTION MAY OCCUR UP TO SEVERAL HOURS AFTER THE FRICTION EVENT. THUS, THE TIMING OF THE APPEARANCE OF BLISTERS SUGGESTS THAT THE BLISTERS WERE CAUSED BY FRICTION, AND NOT AS A RESULT OF A BURN. SINCE NO MALFUNCTION WAS DETECTED IN THE DEVICE ITSELF, AND AS SUGGESTED IN THE ARTICLE, THE LESION MAY HAVE BEEN CAUSED BY THE USE OF INCOMPATIBLE COUPLING MEDIUM. HOWEVER, WE CANNOT RULE OUT THE POSSIBILITY THAT A COMMON POST-ESWL HEMATOMA WAS AGGRAVATED WHILE THE PATIENT WAS AT HOME, MAYBE DUE TO OVER EXCESSIVE CARE. DUE TO THE ABOVE, AS WELL AS DUE TO LACK OF INFORMATION AS TO THE COUPLING MATERIAL USED, MEDISPEC IS UNABLE TO DETERMINE THE RELATEDNESS OF THE BLISTERS AND RESULTING SCAR TO THE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO AN ARTICLE PUBLISHED IN (B)(6) ON (B)(6) 2012, A (B)(6) MALE PRESENTED WITH GROSS HEMATURIA AND LEFT-FLANK PAIN OPTED FOR SHOCKWAVE LITHOTRIPSY (SWL) TREATMENT WITH MEDISPEC EM1000 (ELECTROMAGNETIC LITHOTRIPTER). FOUR THOUSAND SHOCKS (2000 TO EACH CALCULUS) WERE DELIVERED AT 90 SHOCKS/MINUTE AFTER GRADUALLY INCREASING THE POWER TO 20KV. THE MEDISPEC TECHNICIAN DID NOT HAVE THE STANDARD COUPLING GEL RECOMMENDED BY MEDISPEC AND INSTEAD USED ULTRASOUND GEL AVAILABLE FROM THE HOSPITAL. IN THE RECOVERY UNIT, THE ENTIRE SKIN OVERLYING THE AREA WHERE THE GEL HAD BEEN PLACED WAS NOTED TO BE MODERATELY ERYTHEMATOUS WITH 3-4 CM CENTRAL AREA OF SUBCUTANEOUS HEMORRHAGE. THE PATIENT RETURNED ON POSTOPERATIVE DAY 1 WITH SIGNIFICANTLY INCREASED ERYTHEMA AND THE DEVELOPMENT OF LARGE BLISTERS. THE BURN SURGERY SERVICE WAS CONSULTED. A SECOND-DEGREE BURN WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECNOLITH EM1000 LNS MEDISPEC, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| S ASPIRIN: 81 MG| ALLOPURINOL: 300 MG