BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 12679257 · Received October 22, 2021

    Report

    Report Number
    3001431138-2021-00014
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 22, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE THE MANUFACTURER OF THE DEVICE PERFORMED OUR OWN INVESTIGATION, BASED ON THE DATA PROVIDED BY THE US IMPORTER. BASED ON THAT IS POSSIBLE TO CONCLUDE THAT THE SCANNER WAS NOT SECURELY TIGHTEN ON THE ARTICULATED ARM AS REQUIRED BY THE OPERATOR'S MANUAL OM103P1_G.V07 (ACTUAL REVISION SHIPPED WITH THE DEVICE). IN FACT IN THE OPERATOR'S MANUAL 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. MOREOVER THE PHYSICIAN WAS KEEPING THE PEDAL PRESSED WHILE ATTEMPTING TO TIGHTEN THE SCANNER, BY TURNING ON THE WRONG SENSE OF ROTATION (CAUSING THE UNSCREWING OF THE SCANNER INSTEAD OF TIGHTENING), WHICH CAUSED THE DEVICE TO EMIT WHEN THE SCANNER HAS DETACHED. IF THE PEDAL WAS NOT PRESSED, AS REQUIRED WHEN NOT PERFORMING A TREATMENT, THE ACCIDENTAL RADIATION OCCURENCE WOULD HAD NOT OCCURRED. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED BY CYNOSURE'S AUTHORIZED TECHNICIAN AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS (SERVICE REPORT CODE 220001047 PERFORMED IN DATE (B)(6) 2021). THE EVENT TOOK PLACE AT (B)(6) USA. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY WAS RESPONSIBLE FOR CAUSING THE EVENT INSTEAD IS POSSIBLE TO CONCLUDE THAT THE EVENT HAS BEEN CAUSED BY A FAILURE OF THE OPERATOR TO FOLLOW INSTRUCTION (CORRECTLY PERFORM MAINTENANCE ON THE SCANNER AND PERFORM MAINTENANCE OPERATION ON THE SCANNER WHILE KEEPING THE EMISSION PEDAL PRESSED). DUE TO THE FACT THAT THE DEVICE IS WORKING PROPERLY WITHIN SPECIFICATIONS, NO CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THE PRESENT FOLLOW-UP REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2021, EL. EN. ELECTRONIC ENGINEERING (B)(4) BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER (B)(4), THAT RECEIVED A COMMUNICATION FROM THE CLINIC CONCERNING A MALFUNCTION IN WHICH THE SCANNER DETACHED FROM THE ARTICULATED ARM. 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 (B)(4) AND MARKETED IN THE US WITH 510(K) K133895. THE US IMPORTER CYNOSURE REPORTED IN ITS NARRATIVE OF THE EVENT THAT THE PHYSICIAN REPORTED MILD BURN DUE TO THE DETACHMENT OF THE SCANNER. THE EVENT TOOK PLACE WHILE THE PHYSICIAN WAS KEEPING PRESSED THE PEDAL OF THE DEVICE AN ATTEMPTED TO TIGHTEN THE SCREW-IN CONNECTION BETWEEN THE SCANNER AND THE ARTICULATE ARM. THE PHYSICIAN INSTEAD OF TIGHTENING THE SCREWS PROCEEDED TO UN-SCREW THEM CAUSING THE SCANNER TO FULLY DETACH. THIS EVENT, CONSIDERING THAT THE PHYSICIAN WAS KEEPING THE PEDAL PRESSED DURING THE OPERATIONS, CAUSED AN ACCIDENTAL RADIATION OCCURRENCE (ARO). WE, THE MANUFACTURER OF THE DEVICE, RECEIVED THE RESULTS OF THE INVESTIGATION OF OUR US IMPORTER (B)(4) COMPANY LOCATED IN (B)(4) US, FOR THIS CASE. CYNOSURE INC. ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING (B)(4) MEDICAL DEVICES. WE, THE MANUFACTURER OF DEVICE, EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 1000-1040 THIS EVENT REPRESENT AN ARO (UNWANTED LASER EMISSION) 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. MOREOVER, THE US IMPORTER (B)(4), ALREADY EVALUATED THE EVENT AS REPORTABLE (FOR THE SAME REASON) AND PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR 12222993-2021-00035 IN DATE OCTOBER THE 13TH, 2021. BASED ON THAT, IN ACCORDANCE TO 21 CFR PART 803.50(3), WE AS MANUFACTURER OF THE DEVICE PROCEEDED TO SUBMIT OUR OWN MDR REPORT IN ORDER TO SUBMIT ALL THE MISSING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578095 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1