BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 19916993 · Received August 6, 2024

    Report

    Report Number
    3001431138-2024-00014
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Report Date
    August 6, 2024
    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
    505

    Narratives

    Additional Manufacturer Narrative · 0

    WE AS MANUFACTURER OF THE DEVICE HAVE PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION GATHERED BY THE US IMPORTER FROM THE CLINIC. A TECHNICIAN INSPECTED THE DEVICE IN DATE JULY THE 3RD, 2024. THE DEVICE WAS FOUND TO BE WORKING PROPERLY WITHOUT ANY ISSUE AND WITHIN SPECIFICATIONS. AS A PRECAUTIONARY MEASURE THE TECHNICIAN PROCEEDED TO REPLACE THE FOOT PEDAL. ORDINARY MAINTENANCE AND FULL CHECK ON THE DEVICE WAS PERFORMED AFTERWARDS. DUE TO THE FACT THAT THE DEVICE WAS FOUND TO BE WORKING PROPERLY IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. THE REPLACED FOOT PEDAL HAS BEEN REQUESTED, DESPITE BEING FOUND CORRECTLY WORKING, TO BE SHIPPED BACK FOR ANALYSIS. IN CASE THE INVESTIGATION ON THIS COMPONENT WILL CHANGE THE ROOT CAUSE OF THE EVENT, A DEDICATED FOLLOW-UP REPORT WILL BE PROMPTLY SUBMITTED WITH THE GATHERED INFORMATION. MOREOVER, THE EVENT IS MITIGATED IN ITS POTENTIAL RISK DUE TO THE FACT THAT THE EMISSION, WITH FAILURE OF THE FOOT-PEDAL CAN ONLY TOOK PLACE WITH THE DEVICE IN READY-MODE WHICH REQUIRED THE OPERATOR, PATIENT AND ALL OTHER PERSON PRESENT WITHIN THE DEVICE'S ROOM TO WEAR THE APPROPRIATE SAFETY GOGGLES. NO DESIGN DEFICIENCY HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT. NO CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA IS REQUIRED. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON JULY THE 19TH, 2024, EL. EN. ELECTRONIC ENGINEERING SPA RECEIVED A COMMUNICATION FROM THE US IMPORTER CYNOSURE OF A MALFUNCTION, WITH THE DEVICE ELITE IQ, IN WHICH THE CUSTOMER COMPLAINTS OF THE DEVICE DOUBLE PULSING AND FOOTSWITCH WORKING INTERMITTENTLY. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE (REF: M122B1, S/N: (B)(6)) THAT IS MARKETED IN THE US WITH 510(K) NUMBER K193426 IN THE ABOVE-MENTIONED COMMUNICATION IS REPORTED THE FOLLOWING: CYNOSURE REPORTED THAT THE CLINIC WAS COMPLAINING ABOUT THE DEVICE IN WHICH THE FOOT PEDAL DID NOT WORK PROPERLY AND SOMETIMES DOUBLE PULSES. IN THE COMMUNICATION IS REPORTED THAT NO PATIENT NOR OPERATOR REPORTED ANY INJURY DUE TO THIS MALFUNCTION. THE EVENT TOOK PLACE AT THE LOOK LAB PLACED IN (B)(6). THE PRESENT EVENT HAS BEEN EVALUATED AS A REPORTABLE DUE TO THE FACT THAT THE EVENT REPRESENT AN ACCIDENTAL RADIATION OCCURRENCE (ARO). MOREOVER, THE US IMPORTER, CYNOSURE, PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR1222993-2024-00040 IN DATE JULY THE 26TH, 2024. WE THE MANUFACTURER OF THE DEVICE PROCEEDED TO SUBMIT OUR OWN MDR REPORT, IN ACCORDANCE WITH 21 CFR PART 803.50(2) IN ORDER TO SUPPLY ANY MISSING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636566 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown