BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 11893366 · Received May 27, 2021

    Report

    Report Number
    3001431138-2021-00006
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 27, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE, THE MANUFACTURER OF THE DEVICE PERFORMED OUR INVESTIGATION BY CONTACTING THE SITE IN ORDER TO HAVE AN APPOINTMENT TO INSPECT THE DEVICE AND GATHER ANY ADDITIONAL INFORMATION ABOUT THE STATE OF HEALTH OF THE PATIENT. THE EVENT HAS BEEN EVALUATED BY OUR CLINICAL, RESEARCH AND PRACTISE MANAGER (A PERSON QUALIFIED TO MAKE A MEDICAL JUDGEMENT AS PER 21 CFR PART 803.20(C)(2) THAT CONCLUDED THAT, DESPITE THE FACT THAT THE EMISSION WAS UNINTENDED, IT CAN BE ASSUMED TO A MILD OVERTREATMENT. IN FACT THE AREA TREATED IS VERY LIMITED AND THE ENERGY EMITTED EXACT AS FOR THE TREATMENT BUT MITIGATED BY A VERY HIGH SPEED OF MOVEMENT OF THE LASER BEAM THAT DRASTICALLY LOWERS THE TIME OF PERMANENCE OF THE LASER BEAM ON THE SKIN (REDUCING BOTH THE ABLATIVE AND THERMAL EFFECT OF THE EMISSION ON THE SKIN). THAT SAID IS POSSIBLE TO CONCLUDE THAT THE UNWANTED EMISSION TO WHICH THE PATIENT HAS BEEN EXPOSED IS A LOT LESS INTENSE THAN A TREATMENT'S SINGLE SPOT. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN INSPECTED BY MANUFACTURER'S LOCAL SERVICE TECHNICIAN THAT FOUND THE DEVICE, AND ITS ACCESSORIES, TO BE WORKING PROPERLY WITHIN SPECIFICATIONS (EVALUATION PERFORMED IN DATE 17/05/2021 - SERVICE REPORT (B)(4)). ANYWAY THE LASER HAS BEEN STRESSED IN ORDER TO ATTEMPT TO REPLICATE THE MALFUNCTION BUT UNSUCCESSFULLY: THE MALFUNCTION HAS NOT BEEN REPLICATED. THE TECHNICIAN PROCEEDED ANYWAY TO REPLACE THE SHUTTER ASSEMBLY OF THE DEVICE AS A PREVENTIVE INTERVENTION IN ORDER TO GUARANTEE THE RELIABILITY OF THE DEVICE. THE TECHNICIAN ALSO REQUEST UPDATES ON THE STATE OF HEALTH OF THE PATIENT FOR WHICH THE SITE RESPONDED TO NOT HAVE GOT ANY COMMUNICATION FROM THE PATIENT WHATSOEVER. THIS STRENGTHEN EVEN MORE THE FACT THAT A SERIOUS INJURY WAS NOT DEVELOPED BY THE PATIENT AND WILL NOT EVEN IF A SIMILAR EVENT WOULD RECUR. BASED ON THE INVESTIGATION PERFORMED IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT, BECAUSE THE MALFUNCTION HAPPENED ONLY ONE TIME AND WAS IMPOSSIBLE TO BE REPLICATED BY OUR TECHNICIAN ON THE FIELD. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY WAS RESPONSIBLE FOR CAUSING THE MALFUNCTION. DEVICE WORKING WITHIN SPECIFICATIONS. NO REMEDIAL ACTION REQUIRED THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON MAY THE 4TH, 2021, EL.EN. ELECTRONIC ENGINEERING (B)(4) BECAME AWARE OF A MALFUNCTION, REPORTED BY THE (B)(6) SALES AGENT, THAT RECEIVED A COMMUNICATION FROM THE PHYSICIAN, CONCERNING A MALFUNCTION HAPPENED TO A PATIENT FOLLOWING A DERMATOLOGIC TREATMENT WITH THE DEKA SMARTXIDE2 LASER MEDICAL DEVICE. THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE2 (REF: M103F1) MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4) IS NOT MARKETED INT HE US. ANYWAY, A SIMILAR DEVICE DEKA SMARTXIDE2 (REF: M103P1) IS MARKETED IN THE UNITED STATES WITH 510(K) NUMBER K133895. THE SALES AGENT REPORTED THAT DR. (B)(6) IS COMPLAINING ABOUT A MALFUNCTION IN WHICH THE SMARTXIDE2 LASER MEDICAL DEVICE, USED WITH ITS ACCESSORY DOT SCANNER, HAS EMITTED LASER RADIATION ONCE THE INTENDED DOTS WERE ALREADY TERMINATED WITH THE SHAPE OF THE AIMING BEAM (THAT TRACE THE SHAPE OF THE SCANNING). THE EXACT DATE OF THE EVENT IS UNKNOWN. THE EVENT TOOK PLACE AT (B)(6). THIS EVENT CAUSED IN THE PATIENT AN UNWANTED LASER RADIATION THAT CONTOURS THE AREA INVOLVED IN THE TREATMENT. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON MAY THE 4TH, 2021 BY EMAIL FROM THE (B)(6) SALES AGENT AND, ACCORDING TO FDA 21 CFR PART 1000-1040 THIS EVENT REPRESENTS 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
    793655 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103F1

    Patients

    Seq Age Sex Outcome Treatment
    1