BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 10377819 · Received August 7, 2020

    Report

    Report Number
    3001431138-2020-00003
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 11, 2020
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K193426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE THE MANUFACTURER OF THE DEVICE PERFORMED AN IN-DEEP INVESTIGATION IN ORDER TO DETERMINE THE ROOT CAUSE OF THE LOSS OF ENERGY EMITTED, IN REFERENCE TO THE SET VALUES. THE ROOT CAUSE OF THE EVENT HAS BEEN IDENTIFIED AS A CONTAMINATION BY PARTICLES ON THE MEASURING DEVICE ON-BOARD OF THE DEVICE. THIS CONTAMINATION CAUSED THE MEASURING MEAN TO NOT WORK PROPERLY AND FAILED TO CORRECTLY READ THE ENERGY EMITTED. IN ORDER TO AVOID SUCH CONTAMINATION THE INTERNAL POWER METER HAS BEEN SEALED BY ADDING AN ANTI-REFLECTING COATED WINDOW. THIS SOLUTION PREVENT ANY CONTAMINANT TO ENTER THE INTEGRATING SPHERE WHERE THE PHOTODETECTOR IS HOUSED. FURTHERMORE A NEW O-RING HAS BEEN USED TO SEAL THE ROD CAVITY IN ORDER TO IMPROVE THE SEALING OF THE LASER SOURCE'S CAVITY AND AVOID CONTAMINATION PARTICLES RELEASING. TO VALIDATE THE ABOVE MENTIONED SOLUTION SEVERAL PRODUCTION DEVICES, NOT INTENDED TO BE PLACED ON THE MARKET, HAS BEEN EQUIPPED WITH THE NEW SEALING AND TESTED ON A SHORT BURN-IN TEST (EQUAL TO THE ESTIMATED TIME OF TREATMENT/SESSION WITH THE DEVICE). MOREOVER, SOME DEVICES HAS BEEN PUT UNDER A LONG-TERM STRESS TEST (EQUAL TO THE ESTIMATED LASER SOURCE SHOTS DURING ITS ESTIMATED LIFE-TIME). ALL THE DEVICES UNDER TEST HAVE REPORTED OPTIMAL RESULTS WITH A STABLE LASER EMISSION, WITHIN THE PERMITTED 20% TOLERANCE FROM THE NOMINAL VALUE, THROUGHOUT THE WHOLE TIME OF TESTING. THE WHOLE TESTING PROCEDURE, RESULTS AND EVALUATION HAS BEEN RECORDED ON A DEDICATED REPORT CODE RSM_REPORT_0C3202 APPROVED IN DATE SEPTEMBER THE 9TH, 2020. BASED ON THE RESULTS OF THE TEST A SPECIFIC CHANGE REQUEST CODE RDM 20/88 (APPROVED IN DATE SEPTEMBER THE 9TH, 2020) HAS BEEN ISSUED IN ORDER TO MANAGE THE CHANGE ON THE DESIGN OF THE INTERNAL POWER METER BY ADDING THE VALIDATED SEALING. AS ACTIONS RELATED TO THIS EVENT WE WILL: 1) UPDATE ALL THE DEVICE NOT YET PLACED ON THE MARKET AND AVAILABLE IN OUR AND CYNOSURE'S (US IMPORTER) WAREHOUSE (STOCK RECOVERY); 2) IMPLEMENT IMMEDIATELY THE CHANGE ON THE DEVICE ACTUALLY IN PRODUCTION ACCORDING TO UPDATED DMR; 3) UPDATE THE DEVICE ALREADY PLACED ON THE MARKET AT THE FIRST AVAILABLE SERVICE VISIT. THIS ACTION IS INTENDED TO IMPROVE THE RELIABILITY OF THE DEVICES AND IS NOT INTENDED TO REDUCE A RISK FOR PATIENT AND OPERATORS HEALTH. ACTION N° 3 HAS TO BE CONSIDERED AS A PREVENTIVE ACTION DUE TO THE FACT THAT NO SIMILAR (ENERGY RELATED ISSUES) FEEDBACKS/COMPLAINT, FROM THE FIELD, HAS EVER BEEN RECORDED UP TO NOW. THIS EVENT DO NOT REPRESENT A REPORT OF CORRECTION AND REMOVAL UNDER FDA 21 CFR PART 806 BASED ON THE EXCEPTIONS DEFINED IN FDA 21 CFR PART 806.1(B)(1). THE EVENT REPRESENT, PARTIALLY, A STOCK RECOVERY. IN ADDITION THE DECREASE IN ENERGY DOES NOT REPRESENT A RISK FOR PATIENTS AND OPERATORS HEALTH BECAUSE THE LOWER LEVEL OF ENERGY DELIVERED CAN ONLY LEAD TO AN INEFFECTIVE TREATMENT. THE INEFFECTIVENESS OF THE TREATMENT, DUE TO THE INTENDED USE OF THE DEVICE AND ITS OPERATIVE PROCEDURES, DOES NOT REPRESENT A RISK TO PATIENTS HEALTH. THAT SAID, THE ACTION APPLICABLE ON THE DEVICES ON THE FIELD WILL NOT REPRESENT A CORRECTION AND REMOVAL BECAUSE THEY ARE NOT FINALIZED TO REDUCE A RISK TO HEALTH BUT ONLY TO IMPROVE THEIR RELIABILITY. THIS REPORT HAS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Additional Manufacturer Narrative · 1

    WE THE MANUFACTURER OF THE DEVICE RECEIVED THE INVESTIGATION PERFORMED BY THE US IMPORTER, (B)(4), IN WHICH IT IS STATED THAT DURING A LIFE TESTING OF DEVICES, PLACED AT THEIR FACILITY (NOT ON THE MARKET), THEY IDENTIFIED A LOSS OF ENERGY EMITTED, IN REFERENCE TO THE SET VALUE, ABOVE THE 30%. THE ACTUAL MEDICAL DEVICES INVOLVED IN THE TESTING, THAT WAS FINALIZED TO VALIDATE A NEW SOFTWARE VERSION (NOT YET RELEASED), ARE 5. ALL OF THEM ARE ELITE IQ MEDICAL DEVICES WITH REF CODE M122B1. FOLLOWING THE SERIAL NUMBERS OF THE DEVICES (3) THAT REPORTED ENERGY ISSUES: (B)(4). (MNF DATE: OCTOBER THE 17TH, 2019 - UDI: (B)(4) - LOW ENERGY ABOVE TOLERABLE 20% (APPROX. 35%). (B)(4). (MNF DATE: MAY THE 18TH, 2020 - (B)(4) - LOW ENERGY ABOVE TOLERABLE 20% (APPROX. 35%). (B)(4). (MNF DATE: MAY THE 19TH, 2020 - UDI:(B)(4) - LOW ENERGY ABOVE TOLERABLE 20% (APPROX. 35%). UP TO NOW NO ISSUES, RELATIVE TO A LOSS OF POWER THAT EXCEED THE 20% FORM THE NOMINAL VALUE, HAVE EVER BEEN RECORDED ON THE FIELD WORLDWIDE. THE INVESTIGATION, TO DETERMINE THE ACTUAL ROOT CAUSE OF THE EVENT, IS STILL ON GOING AT US IMPORTER AND MANUFACTURER LABORATORIES. THAT SAID IT IS NOT POSSIBLEE TO SUPPLY ANY CONCLUSION AT THE TIME OF THIS REPORT, THAT HAS TO BE CONSIDERED ONLY AS AN INITIAL REPORT. A FOLLOW UP REPORT, WITH THE RESULTS OF THE INVESTIGATION AND DEFINITION OF EVENTUAL ACTIONS NEEDED, WILL BE SUPPLIED TO THE FDA WITHIN SEPTEMBER THE 11TH, 2020.

    Description of Event or Problem · 1

    ON JULY THE 22ND 2020, EL. EN. ELECRTONIC ENGINEERING SPA BECAME AWARE OF A MALFUNCTION, REPORTED BY A (B)(6) CUSTOMER TO THE US IMPORTER (B)(4)., RELATIVE TO A 10% LOSS OF ENERGY EMITTED ON AN ELITE IQ MEDICAL DEVICE. THE US IMPORTER THAT HAS PERFORMED A LONG TIME TESTING ON 5 UNITS, AT THEIR FACILITY (NOT ON THE MARKET) RELATIVE TO POWER EMISSION FINALIZED TO THE EVALUATION OF A NEW SOFTWARE VERSION, STILL NOT RELEASED, AND NOTICED A DEVIATION ON POWER ABOVE THE ADMITTED 20%. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT IS AN ELITE IQ. THE ELITE IQ LASER MEDICAL DEVICE IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K193426. THE US IMPORTER (B)(4) WAS PERFORMING A LIFE TESTING ON 5 UNITS OF ELITE IQ AVAILABLE AT THEIR FACILITY IN ORDER TO EVALUATE A NEW SOFTWARE VERSION. DURING THOSE TESTS THEY NOTICED A DECREASE IN POWER OF, AT MAX, 35%. BASED ON THAT THEY INFORMED US OF THE ISSUE AND SUPPLIED ALL THE INFORMATION AVAILABLE RELATIVE TO THE TESTS THEY HAVE PERFORMED. UP TO DATE NO ISSUES FROM THE FIELD , RELATIVE TO A LOSS OF POWER THAT EXCEED THE 20% FORM THE NOMINAL VALUE, HAS BEEN RECORDED BY NEITHER CYNOSURE OR THE MANUFACTURER. CYNOSURE INC. ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. (B)(4). EVALUATED THE EVENT AS REPORTABLE BECAUSE IT REPRESENT AN ARO AND SUBMITTED ITS OWN MDR REPORT #MDR1222993-2020-00019 IN DATE AUGUST THE 5TH 2020. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JULY THE 22ND 2020 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803.50(B)(2), SUBMITTED TO FDA AN OWN MDR REPORT IN ORDER TO SUBMIT ADDITIONAL INFORMATION FORM THE REPORT SUBMITTED BY THE US IMPORTER. MOREOVER, WE EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 1000-1040 THIS EVENT REPRESENT AN ARO 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, DUE TO THE FACT THAT ALL THE DEVICES ARE NOT ON THE MARKET, THIS EVENT DO NOT REPRESENT A REPORT OF CORRECTION AND REMOVAL UNDER FDA 21 CFR PART 806 BASED ON THE EXCEPTIONS DEFINED IN FDA 21 CFR PART 806.1(B)(1). THE EVENT REPRESENT A STOCK RECOVERY. IN ADDITION THE DECREASE IN ENERGY DOES NOT REPRESENT A RISK FOR PATIENTS AND OPERATORS HEALTH BECAUSE THE LOWER LEVEL OF ENERGY DELIVERED CAN ONLY LEAD TO AN INEFFECTIVE TREATMENT. THE INEFFECTIVENESS OF THE TREATMENT, DUE TO THE INTENDED USE OF THE DEVICE AND ITS OPERATIVE PROCEDURES, DOES NOT REPRESENT A RISK TO PATIENTS HEALTH. THAT SAID, ANY EVENTUAL ACTION THAT WILL BE NEEDED TO EVALUATE THE DEVICES ON THE FIELD WILL NOT REPRESENT A CORRECTION AND REMOVAL BECAUSE THEY ARE NOT FINALIZED TO REDUCE A RISK TO HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843260 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1

    Patients

    Seq Age Sex Outcome Treatment
    1