BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 9161299 · Received October 7, 2019

    Report

    Report Number
    3001431138-2019-00011
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    September 5, 2019
    Report Date
    October 7, 2019
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE THE MANUFACTURER OF THE DEVICE RECEIVED THE INVESTIGATION PERFORMED BY THE US IMPORTER, CYNOSURE INC, IN WHICH IT IS STATED THAT THE SCANNER OF THE DEVICE WAS LOOSE AND DETACHED CAUSING AN ACCIDENTAL RADIATION OCCURENCE FROM THE END OF THE ARTICULATED ARM WERE THE SCANNER WAS ATTACHED. THE LASER BEAM HIT THE NECK OF THE OPERATOR CAUSING HIM A BURN. THE SITE, DESPITE SEVERAL REQUEST OF THE US IMPORTER FOR ADDITIONAL INFORMATION, HAVE NOT DISCLOSED AY ADDITIONAL INFORMATION. THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED IN DATE SEPTEMBER THE 9TH 2019 AND FOUND TO BE WORKING PROPERLY. NO PROBLEM TO THE SCANNER NOR ITS CONNECTION WITH THE ARTICULATED ARM WAS FOUND. THE LASER ENERGIES WERE TESTED AND FOUND CORRECT(CYNOSURE'S SERVICE REPORT # (B)(4)). THE TECHNICIAN ANYWAY FOUND THE SCANNER LOOSE ON THE DEVICE PRIOR TO THE INTERVENTION. HE THEN PROCEEDED TO SECURELY TIGHTEN THE SCANNER ON THE ARTICULATED ARM BASED ON THE INFORMATION GATHERED BY THE US IMPORTER, WE THE MANUFACTURE OF THE DEVICE, CDID NOT CONCLUDE THAT A DESIGN DEFICIENCY OR DEVICE MALFUNCTIONING WAS RESPONSIBLE FOR CAUSING THE EVENT. RATHER, IT COULD BE ASSUMED THAT THERE WAS A HUMAN FACTORS ISSUE, WHERE A FAILURE TO PROPERLY SET UP OF THE DEVICE PRIOR TO THE TREATMENT. IN FACT THE OPERATOR'S MANUAL CODE OM103P1_G.V03 (ACTUAL REVISION DELIVERED WITH THE DEVICE) AT CHAPTER 9.1 (INSTALLATION OF SCANNING UNITS) IS CLEARLY HIGHLIGHTED THAT THE SCANNER IS A DETACHABLE PART OF THE DEVICE AND IT REQUIRES TO BE CORRECTLY AND FIRMLY SCREWED TO THE ARTICULATED ARM BEFORE TREATMENT. THE DEVICE IS WORKING PROPERLY SO NO REMEDIAL ACTION IS REQUIRED. THE OPERATOR'S MANUAL AND THE RISK MANAGEMENT FILE HAVE BEEN EVALUATED AND FOUND ADEQUATE. THIS INITIAL REPORT HAS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON SEPTEMBER THE 30TH 2019, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER CYNOSURE INC., THAT RECEIVED A COMMUNICATION FROM THE CLINIC CONCERNING AN ADVERSE EVENT IN WHICH THE SCANNER HAS DETACHED AND CAUSED BURNS ON THE OPERATOR'S NECK. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE2. THE DEKA SMARTXIDE2 LASER MEDICAL DEVICE IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K133895. THE US IMPORTER CYNOSURE REPORTED THAT DURING A TREATMENT THE DEVICE'S SCANNER HAS DETACHED AND AN ACCIDENTAL RADIATION OCCURRENCE (ARO) HAPPENED FROM THE END OF THE ARTICULATED ARM WHERE THE SCANNER WAS ATTACHED. THE US IMPORTER REPORTED THAT ADDITIONAL INFORMATION WERE REQUESTED TO THE SITE BUT NO RESPONSE WERE RECEIVED. WE, THE MANUFACTURER OF THE DEVICE, RECEIVED THE RESULTS OF THE INVESTIGATION OF OUR US IMPORTER CYNOSURE INC. COMPANY LOCATED IN (B)(6) FOR THIS CASE. CYNOSURE INC. ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. CYNOSURE INC. EVALUATED THE EVENT AS REPORTABLE BECAUSE IT REPRESENT AN ARO AND SUBMITTED ITS OWN MDR REPORT #MDR-1222993-2019-00024 IN DATE OCTOBER THE 1ST, 2019. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON SEPTEMBER THE 30TH, 2019 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803.50(B)(2), SUBMITTED TO FDA AN OWN MDR REPORT IN ORDER TO SUBMIT ADDITIONAL INFORMATION FORM THE REPORT SUBMITTED BY THE US IMPORTER. MOREOVER, WE EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 1000-1040 THIS EVENT REPRESENT AN ARO AND IS A REPORTABLE EVENT. THAT SAID, ACCORDING TO FDA 21 CFR PART 1003.10(C) IF THE MANUFACTURER IS REQUIRED TO REPORT TO THE FOOD AND DRUG ADMINISTRATION UNDER PART 803 OF THIS CHAPTER, THE MANUFACTURER SHALL REPORT IN ACCORDANCE WITH PART 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955195 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other