BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 23062207 · Received September 16, 2025

    Report

    Report Number
    3001431138-2025-00007
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Report Date
    September 16, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE AS MANUFACTURER OF THE DEVICE INVOLVED IN THE EVENT PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION SHARED BY THE US IMPORTER. IN DATE 06/08/2025 A US IMPORTER AUTHORIZED TECHNICIAN PROCEEDED TO INSPECT THE DEVICE AND FOUND THAT THE FINGERSWITCH CABLE IS DAMAGED. THAT SAID, HE PROCEEDED WITH THE REPLACEMENT OF SUCH CABLE AND TESTED THE DEVICE THOROUGHLY. FOLLOWING THE CABLE REPLACEMENT THE DEVICE HAS BEEN RESTORED TO WORKING PROPERLY WITHIN SPECIFICATIONS. THE CLINIC CONFIRMED, TO THE TECHNICIAN, THAT NO PERSON REPORTED ANY INJURY DURING THE EVENT. IT IS NOT POSSIBLE TO EXACTLY DETERMINE THE ROOT CAUSE OF THE EVENT WHILE IT IS POSSIBLE TO HYPOTHESIZE THAT THE CABLE HAS WORN-OUT DUE TO USAGE OF THE DEVICE. ANYWAY, PERFORMED AN ANALYSIS OF PREVIOUS SIMILAR CASES RECORDED IN THE EXPECTED SERVICE LIFE TIME-SPAN (5 YEARS) AND FOUND THAT THE PROBABILITY OF OCCURRENCE OF SUCH EVENT IS 0.08%. THAT SAID NO CORRECTIVE ACTION IS DEEMED NECESSARY FOR THIS CASE. BASED ON WHAT REPORTED ABOVE IS POSSIBLE TO CONCLUDE THAT THE MOST PROBABLE CAUSE OF THE EVENT IS A WORN-OUT OF THE COMPONENT AND THAT NO DESIGN ISSUES HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT. THE PRESENT MDR REPORT IS CONSIDERED AS A FINAL REPORT UNLESS FDA HAS MORE QUESTIONS ABOUT IT.

    Description of Event or Problem · 0

    IN DATE 20/08/2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO A MALFUNCTION IN WHICH A CLINIC COMPLAINT OF THE DEVICE FIRING WITHOUT ANY INTERVENTION (ARO) WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. THE CLINIC SEV LASERS (USA) REPORTED TO THE US IMPORTER THAT THE DEVICE WAS FIRING WITHOUT ANY INTERVENTION BY THE USER. THE US IMPORTER CONTACTED THE CLINIC WHICH STATED THAT NO PERSON WERE INJURED DURING THE MISFIRING OF THE DEVICE. CYNOSURE, AS US IMPORTER OF THE DEVICE, HAVE ALREADY REPORTED THIS CASE TO THE US FDA WITH A DEDICATED MDR REPORT CODE MDR1222993-2025-00028 IN DATE AUGUST THE 25TH, 2025. BASED ON THAT, IN ACCORDANCE WITH 21 CFR PART 803.50(B)(2) WE AS MANUFACTURER OF THE DEVICE ARE OBLIGED TO SUBMIT OUR OWN REPORT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673676 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown