BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 15066960 · Received July 20, 2022

    Report

    Report Number
    3001431138-2022-00009
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 20, 2022
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08057017760450
    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 INVOVLED IN THE EVEN THAS BEEN EVALUATED IN DATE JUNE THE 21ST 2022 AND FOUND TO BE EMITTING, AT LASER APERTURE, A VALUE BELOW MORE THAN THE 20% FROM THE NOMIAL VALUE SET ON THE DEVICE. THE TECHNICIAN FOUND THAT THE AIMING BEAM WAS NOT AS USUALLY SHAPED AND SUSPECTED THAT THE FOCUSING LENS AND FIBER REPORTED SOME DAMAGE AND/OR MISALIGNEMENT. BASED ON THAT THE TECHNICIAN FOLLOWED UP WITH THE CLIENT THE FOLLOWING DAY AND PROCEEDED TO REPLACE BOTH THE FIBER AND FOCUSING LENS ON THE HANDPCIE. FOLLWING THE REPLACEMENT THE DEVICE WAS CALIBRATED AND LEFT CORRECTLY WORKING WITHIN MANUFACTURER'S SPECIFICATIONS. AS REPORTED BY THE SITE NO PATIENT REPORTED ANY IMPACTS OR INJURY BUT JUST A MILD DISCOMFORT DURING THREATEMENT THAT WERE ANYWAY ADMINISTRATED JUST BY USING MORE COOLING DURING THE TREATMENT. DUE TO THE NATURE OF THE TREATMENT (HAIR REMOVAL) AN EMISSION BELOW THE 20% OF TOLERANCE CANNOT LEAD TO INJURY TO PATIENT BUT ONLY TO AN EVENTUAL LESS EFFICACY IN THE TREATMENT. DUE TO THE NATURE OF THE TREATMENT PERFORMED THIS COULD NOT LED TO ANY DIRECT HARM OR THE NECESSITY OF PARTICULAR MEDICAL ATTENTION. THE ACTUAL CAUSE OF THE EVENT CANNOT BE ESTABLISHED DUE TO THE FACT THAT THE MISILIGNEMENT OF THE LENS OR DAMANGE TO THE FIBER CAN BE CAUSED BY SEVERAL FACTORS SUCH AS DROPPING OF THE HANDPCIE OR PULL ON THE FIBER. THIS FAULT COULD HAVE BEEN DETECTED BY THE USER, PRIOR TO THE TREATMENT, BY ANALYSING THE SHAPE OF THE AIMING BEAM (AS SEEN BY THE TECHNICIAN) AS REPORTED ON THE OPERATOR'S MANUAL CODE OM122B1-D1_G.V07 (ACTUAL REVISON SHIPPED WITHTHE DEVICE) AT CHAPTER "HANDPICES". 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 THE MISALIGNMENT OF THE FOCUSING LENS/FIBER. DUE TO THE FACT THAT THE DEVICE HAS BEEN ALREADY REPAIRED AND LEFT WORKING PROPERLY WITHIN SPECIFICATIONS AND THAT NO DESIGN DEFICENCY HAS ARISE, 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 JUNE THE 30TH 2022, EL. EN. ELECRTONIC 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 WAS FOUND EMITTING LOWER THAN THE 20% FROM THE NOMINAL VALUE SET ON THE DEVICE. 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, THE SERVICE WAS CALLED DUE TO THE FACT THAT THE PATIENT FELT THE TREATMENT TO BE MORE UNCOMFORTABLE, DESPITE WITHOUT ANY IMPACT SUCH AS BURNS. THE CLINIC REPORTED TO THE US IMPORTER THAT PATIENT FELT MORE DISCOMFORT AND MORE HEAT SINCE PREVIOUS TREATMENTS BUT MANAGED THE TREATMENT WITHOUT ANY COMPLICATIONS. THE SITE WAS INSTRUCTED BY THE US IMPORTER TO USE THE COOLER AT OPTIMAL LEVELS TO ASSIST IN PATIENT COMFORT. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN INITIALLY EVALUATED IN DATE 21/06/2022 IN WHICH THE DEVICE HAS BEEN FOUND TO EMIT BELOW THE 20% OF TOLERANCE WITH THE ALEX LASER SOURCE. NO INJURY TO PATIENT OR OPERATOR HAS BEEN REPORTED. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JUNE THE 30TH 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 (LASER EMISSION BELOW THE 20% TOLERANCE FROM THE NOMINAL VALUE ET ONTHE DEVICE) 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 12222993-2022-00028 IN DATE JULY THE 19TH, 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
    964561 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown