BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 12505221 · Received September 21, 2021

    Report

    Report Number
    3001431138-2021-00012
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    April 30, 2021
    Report Date
    September 21, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08057017760450
    PMA / PMN Number
    K193426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE, THE MANUFACTURER OF THE DEVICE, AND OUR US IMPORTER PERFORMED OUR INVESTIGATION BY CONTACTING THE SITE IN ORDER TO GATHER MORE DETAILED INFORMATION ABOUT THE EVENT. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED BY (B)(4) AUTHORIZED TECHNICIAN IN DATE AUGUST THE 20TH, 2021 AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. ALL THE ENERGY EMISSION OF THE DEVICE HAS BEEN EVALUATED AND FOUND WELL WITHIN TOLERANCES. BASED ON THE NARRATIVE PROVIDED BY THE US IMPORTER IS POSSIBLE TO CONCLUDE THAT THE EVENT HAS BEEN CAUSED BY AN OVERLAPPING OF TREATMENT ON THE AREA WHICH CAUSED THE DELIVERY TO THE PATIENT OF TOO MUCH ENERGY THAT CAUSED THE LESIONS. THE OPERATOR'S MANUAL OF THE DEVICE CODE OM122B1-D1_G.V04 (ACTUAL REVISION SHIPPED WITH THE DEVICE) CLEARLY STATES AT CHAPTER "TREATMENT RECOMMENDATION" AND "STEP-BY-STEP PROCEDURE FOR TREATMENT" TO NEVER OVERLAP THE TREATMENT IN ORDER TO AVOID THE ADMINISTRATION OF TOO MUCH ENERGY TO THE PATIENT. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY OR DEVICE MALFUNCTIONING WAS RESPONSIBLE FOR CAUSING THE EVENT INSTEAD IS POSSIBLE TO CONCLUDE THAT THE ADVERSE EVENT CAN BE TRACED TO A USER ERROR WHERE THE PHYSICIAN FAILED TO CORRECTLY PERFORM THE TREATMENT AND OVERLAPPED THE SHOTS SEVERAL TIMES. DEVICE WORKING WITHIN SPECIFICATIONS. NO REMEDIAL ACTION REQUIRED. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON AUGUST THE 28TH, 2021, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY US IMPORTER (B)(4), CONCERNING AN ADVERSE EVENT REPORTED TO THEM FROM THE CLINIC, FOLLOWING A VASCULAR TREATMENT DURING A TRAINING SESSION AT PHYSICIAN SITE. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE REF: M122B1 S/N: (B)(4). THE ACTUAL DEVICE INVOLVED IN THE EVENT IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K193426. IN THE COMMUNICATION AND INVESTIGATION PERFORMED ON SITE BY THE US IMPORTER IS REPORTED THE FOLLOWING: THE CLINICAL EDUCATION SPECIALIST, (B)(6), STATED THAT IN DATE (B)(6) 2021, THE PROVIDER LOST TRACK OF WHERE SHE HAD ALREADY TREATED THE PATIENT. THE EDUCATOR REQUESTED THE PROVIDER TO STOP TREATMENT AND SHE DID AS REQUESTED. THE PROVIDER THAN WENT BACK TO THE MIDDLE OF THE TREATED AREA (BACK OF THE KNEE) WHERE SHE ALREADY DELIVERED THE TREATMENT. THE EDUCATOR AGAIN REQUESTED THE PROVIDER TO STOP TREATMENT. ANYWAY THE PROVIDER RESTARTED THE PROTOCOL AND COMPLETED THE REST OF THE AREA. THE END POINT OF THE TREATED AREA WAS A MILD ERYTHEMA POST TREATMENT. THE PATIENT WAS GIVEN POST CARE INSTRUCTION AND TO CONTACT THE PROVIDER FOR ANY NEEDS. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON AUGST THE 27TH 2021 BY US IMPORTER (B)(4) AND EVALUATED THE EVENT REPORTABLE BECAUSE THE LESION REPORTED BY THE PATIENT ARE CONSIDERED SERIOUS INJURIES. 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 12222993-2021-00032 IN DATE AUGUST THE 31TH, 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
    1407266 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other