BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 8849669 · Received August 1, 2019

    Report

    Report Number
    3001431138-2019-00007
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    June 12, 2019
    Report Date
    August 1, 2019
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Product Problem
    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 SITE REPORTED OF A PIECE OF PAPER TOWEL PREVIOUSLY USED FOR THE CLEANING OF THE HANDPIECE HAVE BEEN LEFT INSIDE IT AND TOOK FIRE DURING THE TEST SHOT. THE SITE CONFIRMED THAT NO ONE HAVE BEEN HARMED AND NO INJURY HAVE BEEN CAUSED TO ANYONE. THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED IN DATE (B)(6) 2019 AND FOUND TO BE WORKING PROPERLY. THE HANDPIECE HAVE BEEN CLEANED BY THE TECHNICIAN FROM ANY BURNT RESIDUAL AND EVALUATED. THE HANDPIECE WAS STILL WORKING PROPERLY (CYNOSURE'S SERVICE REPORT # (B)(4)). BASED ON THE INFORMATION GATHERED BY THE US IMPORTER, WE THE MANUFACTURE OF THE DEVICE, CONCLUDED THAT THE EVENT HAS BEEN CAUSED BY A USER ERROR DURING THE CLEANING OF THE HANDPIECE. IN FACT THE OPERATOR'S MANUAL CODE OM103P1_G.V05 (ACTUAL REVISION DELIVERED WITH THE DEVICE) AT CHAPTER 13.1.1, POINT D, STEP 5 RELATIVE TO THE CLEANING OF THE REUSABLE PARTS IT IS STATED THAT "INSPECT ITEMS VISUALLY TO CONFIRM THAT THEY ARE CLEAN. IF ANY VISIBLE DEBRIS REMAINS, REPEAT STEPS ABOVE.". THIS CHECK HAS NOT BEEN PERFORMED BY THE PERSONNEL IN CHARGE OF THE CLEANING AND THE PIECE OF TOWEL HAVE BEEN LEFT IN THE HANDPICE. 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 IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON JULY THE 12TH 2019, EL. EN. ELECRTONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER CYNOSURE INC., THAT RECEIVED A COMMUNICATION FROM THE CLINIC CONCERNING A MALFUNCTION IN WHICH A PAPER TOWEL LEFT IN THE HANDPIECE DURING THE CLEANING PROCESSES HAVE TOOK FIRE. 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 BEFORE THE TREATMENT OF THE PATIENT THE PHYSICIAN PERFORMED A TEST SHOT OF THE DEVICE AND THE HANDPIECE TOOK ON FIRE. AS REPORTED BY THE SITE TO CYNOSURE IT HAS BEEN FOUND THAT, DURING THE CLEANING OPERATION THAT HAVE TO BE PERFORMED BEFORE THE STERILIZATION OF THE HANDPIECE, A PIECE OF CLEANING CLOTH HAS BEEN LEFT INSIDE THE HANDPIECE. THE HANDPIECE HAS BEEN SUCCESSIVELY STERILIZED AND AT THE FIRST USE OF THAT HANDPIECE THE PIECE OF CLOTH, THAT HAVE OBSTRUCTED THE LASER PATH, HAS BEEN IGNITED. THE SITE HAVE CONFIRMED THAT NO PATIENT NOR THE OPERATOR HAVE BEEN INJURED DURING THE EVENT. WE, THE MANUFACTURER OF THE DEVICE, RECEIVED THE RESULTS OF THE INVESTIGATION OF OUR US IMPORTER CYNOSURE INC. COMPANY LOCATED IN (B)(4), 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 THE MALFUNTION COULD HAVE CAUSED INJURY TO PATIENT AND/OR OPERATOR AND SUBMITTED ITS OWN MDR REPORT #MDR-1222993-2019-00012 IN DATE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645583 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1