BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 14099534 · Received April 13, 2022

    Report

    Report Number
    3001431138-2022-00004
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    March 1, 2022
    Report Date
    April 13, 2022
    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 · 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 INFORMATION DISCLOSED RELATIVE TO THE PATIENT (PICTURES OF THE LESIONS) AS WELL AS THE PARAMETERS USED FOR THE TREATMENT HAS BEEN EVALUATED BY OUR MANAGER OF CLINICAL RESEARCH AND PRACTISE AND HIS CONCLUSIONS ARE THE FOLLOWING: THE ROOT CAUSE OF THE EVENT IS THE USAGE OF WRONG HANDPIECE FOR THE TREATMENT IN RELATION TO THE PATIENT'S CONDITIONS. SPECIFICALLY THE VESSEL OF THE PATIENT WERE TOO LARGE FOR THE USE OF THE 5MM HANDPIECE; INSTEAD, AS REPORTED ON THE ELITE IQ CLINICAL REFERENCE GUIDELINES CODE (B)(4) THE APPROPRIATE HANDPIECE FOR VESSELS LARGER THAN 1MM IS THE 7 MM HANDPIECE. THE USE OF A TOO NARROW SPOT CAUSED THE DELIVERY OF A TOO MUCH AGGRESSIVE TREATMENT THAT CAUSED AN INITIAL ERYTHEMA THAT DEVELOPED IN BRUNS AND OPEN SORES. AS SPECIFIED IN THE DEVICE'S OPERATOR'S MANUAL CODE (B)(4) (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER 'ADVERSE EFFECTS' BURNS AND ERYTHEMA ARE A FORESEEABLE SIDE EFFECT. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN EVALUATED BY (B)(4) AUTHORIZED LOCAL TECHNICIAN IN DATE MARCH THE 11TH, 2022 AND FOUND CORRECTLY WORKING WITHIN SPECIFICATIONS (SERVICE REPORT (B)(4)). 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 A FAILURE OF THE OPERATOR TO PROPERLY EVALUATE THE CORRECT PROCEDURES IN REFERENCE TO THE PATIENT'S CONDITION OF THE TREATMENT AREA (USE OF TOO MUCH AGGRESSIVE PARAMETERS). DUE TO THE FACT THAT THE DEVICE IS WORKING PROPERLY WITHIN SPECIFICATIONS, 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 MARCH THE 29TH 2022, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER, (B)(4), IN WHICH IT IS STATED THAT A PATIENT DEVELOPED OPEN SORES AND BURNS FOLLOWING A VASCULAR TREATMENT WITH THE ELITE IQ LASER MEDICAL 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 INVOLVED IN THE EVENT IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K193426. THE EVENT TOOK PLACE AT (B)(6). IN THE NARRATIVE PROVIDED OF THE EVENT IT IS STATED THAT THE PATIENT WAS UNDERGOING A VASCULAR TREATMENT ON THE LEG AREA. THE PARAMETERS USED FOR THE TREATMENT, PERFORMED ON DATE (B)(6) 2022, ARE: 5 MM HANDPIECE, 130J/CM2, 30MS WITH THE 1064 NM LASER SOURCE (ND: YAG). THE PATIENT HAVE A TYPE SKIN II (FITZPATRICK SCALE). FOLLOWING THE TREATMENT THE PATIENT RECEIVED MEDICAL ATTENTION AND WAS PRESCRIBER WITH BACTORAN CREAM AS A PREVENTIVE MEDICATION. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON MARCH THE 29TH 2022 BY SPECIFIC COMMUNICATION OF THE US IMPORTER, (B)(4), AND EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 803 THIS EVENT REPRESENT A SERIOUS INJURY DUE TO THE FACT THAT THE PATIENT RECEIVED MEDICAL ATTENTION AND BECAUSE IT COULD LEAD TO A PERMANENT INJURY (EVALUATION PERFORMED ON AN ABUNDANCE OF CAUTION). 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 12222993-2022-00010 IN DATE MARCH THE 30TH, 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
    2564347 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other