BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 15734064 · Received November 4, 2022

    Report

    Report Number
    3001431138-2022-00010
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 3, 2022
    Report Date
    November 4, 2022
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K193426
    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 AND PICTURES DISCLOSED BY THE US IMPORTER WHICH ARE THE FOLLOWING: THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVEN HAS BEEN EVALUATED IN DATE (B)(6) 2022 AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. SERVICE FIELD TECHNICIAN ATTEMPTED TO REPLICATE THE FAILURE COMPLAINED BY THE CUSTOMER UNSUCCESSFULLY. THE DEVICE HAS BEEN CHECKED IN ALL ITS PARTS, CONNECTIONS AND EMISSION POWER AND FOUND WELL WITHIN SPECIFICATIONS. TO FOLLOW-UP ON PATIENT'S INFORMATION CYNOSURE (US IMPORTER) CONTACTED THE SITE IN ORDER TO HAVE MORE DETAILED ABOUT THE LESION REPORTED BY THE TWO PATIENTS. THE SITE DISCLOSED THAT FOR ONE PATIENT THERE WAS NO BURNS BUT ONLY A MILD REACTION ON THE SKIN WHILE FOR THE SECONDO PATIENT THE BURNS ARE MINOR. MILD BURNS ARE FORESEEABLE SIDE EFFECT OF THE TREATMENT AS SPECIFIED ON THE OPERATOR'S MANUAL CODE OM122B1-D1_G.V07 (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER 9 "ADVERSE EFFECTS". US IMPORTER ALSO PROVIDED THE LOG FILE OF THE DEVICE THAT HAS BEEN EVALUATED ALSO BY THE EL.EN.'S SERVICE AND TECHNICAL PERSONNEL THAT CONCLUDED: THE TWO ALARMS REPORTED TOOK PLACE SEVERAL DAYS BEFORE THE ACTUAL EVENT AND CANNOT BE RELATED TO IT. THE LOGS OF THE DAY OF THE EVENT DO NOT SHOW ANY ABNORMALITY WITH ALL DATA AND VALUES WITHIN SPECIFICATIONS AND WITHOUT ANY ALARM. ALL THE DATA AVAILABLE CONFIRMS THE INITIAL EVALUATION OF CYNOSURE'S TECHNICIAN WHO INSPECTED THE DEVICE AT THE SITE. THE ACTUAL CAUSE OF THE EVENT CANNOT BE ESTABLISHED DUE TO THE FACT THAT THE FAILURE WAS IMPOSSIBLE TO REPLICATE AND ALL THE INFORMATION AVAILABLE DID NOT SHOW ANY MALFUNCTION ON THE DEVICE ITSELF. MOREOVER, IT IS NOT POSSIBLE TO CLEARLY DEFINE IF THE MALFUNCTION REPORTED BY THE SITE CONTRIBUTED TO PATIENT'S DISCOMFORT/MINOR INJURY. DUE TO THE FACT THAT THE DEVICE HAS BEEN FOUND WORKING PROPERLY WITHIN SPECIFICATIONS AND THAT NO DESIGN DEFICIENCY HAS ARISEN, NO CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF A MALFUNCTION, REPORTED BY THE US IMPORTER, CYNOSURE, IN WHICH IT IS STATED THAT AN ELITE IQ LASER MEDICAL DEVICE THAT SHOT UNINTENTIONALLY WITHOUT THE PRESSURE OF THE FINGER-SWITCH. MOREOVER IT IS REPORTED THAT TWO PATIENTS WERE INVOLVED IN THE EVENT. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE REF: M122B1 S/N: (B)(4), UDI: ((B)(4). THE ACTUAL DEVICE INVOVLED IN THE EVENT IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K193426. BASED ON THE NARRATIVE PROVIDED BY THE US IMPORTER, CYNOSURE, IT IS REPORTED THAT THE LASER WAS FIRING WITHOUT THE PUSHING OF THE FINGER-SWITCH. A MESSAGE ON THE LASER STATED TO RELEASE THE BUTTON ON THE HP, THE LASER PULSED FOR ABOUT FIVE TIMES AND THAT WENT TO CALIBRATION. IT IS NOT CLEAR IF THE LESION TO THE PATIENTS WERE OCCURRED DUE TO THE PULSING OF THE LASER BUT THE SITE HAS REPORTED THE BURN OF TWO PATIENT IN THE DATE OF THE EVENT (B)(6) 2022. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN INITIALLY EVALUATED IN DATE OCTOBER THE 4TH, 2022 IN WHICH THE DEVICE HAS BEEN FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2022 BY SPECIFIC COMMUNICATION OF THE US IMPORTER, CYNOSURE, AND EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 1000-1040 THIS EVENT REPRESENT AN ARO (UNANTICIPATED 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 CYNOSURE, ALREADY EVALUATED THE EVENT AS REPORTABLE (FOR THE SAME REASON) AND PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR 12222993-2022-00038 IN DATE (B)(6) 2022. 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
    2227956 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown