BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKA MOTUS AX

    MDR report key: 16511711 · Received March 9, 2023

    Report

    Report Number
    3001431138-2023-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 25, 2023
    Report Date
    March 9, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K162886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE THE MANUFACTURER OF THE DEVICE PERFORMED OUR OWN INVESTIGATION, BASED ON THE DATA AND PICTURES DISCLOSED BY THE GERMAN DISTRIBUTOR WHICH ARE THE FOLLOWING: THE DETECTION OF A BROKEN FIBER CAN BE DETECTED BY OBSERVING THE QUALITY/PRESENCE OF THE AIMING BEAM DURING THE USE OF THE LASER MEDICAL DEVICE. FOR THIS REASON THE OPERATOR HAS BEEN INTERVIEWED BY THE TECHNICIAN WHO ASKED IF THEY NOTED ANY DIFFERENCE ON THE AIMING BEAM (WHICH COULD HAVE IDENTIFIED AN EVENTUAL DEGRADATION OF THE FIBER/OPTICAL PATH OF THE LASER) BUT THE PHYSICIAN ANSWERED THAT THEY HAVE NOT NOTICED ANY DIFFERENCE ON THE AIMING BEAM BEFORE THE EVENT. THIS LED TO CONCLUDE THAT THE BREAK WAS IMMEDIATE AT THE TIME OF THE EVENT. MOREOVER THE TECHNICIAN REPORTED THAT THE FIBER WAS NOT PLACED PROPERLY ON THE FIBER-BOOM BY THE OPERATOR OF THE DEVICE. IN FACT AS PER OPERATOR'S MANUAL CODE OM112D1_D.V01 (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER 9 'INSTALLATION' THE INSTRUCTION REQUIRES THE OPERATOR TO INSTALL THE FIBER IN ORDER TO HAVE IT REST ON THE DEDICATED HOLDERS AND WITH A DEDICATED LOCK TO PRESERVE THE INTEGRITY AND FUNCTIONALITY OF THE FIBER. THE TECHNICIAN WHO INSPECTED THE DEVICE FOUND THAT THE FIBER WAS TWISTED WITH A VERY LOW RADIUS AROUND THE FIBER BOOM WHICH IS THE MOST PROBABLE CAUSE OF THE FIBER BREAKING. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED IN DATE FEBRUARY THE 28TH 2028 BY LOCAL AUTHORIZED SERVICE TECHNICIAN. THE TECHNICIAN PROCEEDED TO INSPECT THE DEVICE AND FOUND IT WORKING PROPERLY WITHIN SPECIFICATIONS, EXCEPT THE BROKEN FIBER. FOLLOWING THIS INITIAL EVALUATION THE DEVICE HAS BEEN REPAIRED AND RESTORED BY REPLACING THE BROKEN FIBER IN DATE (B)(6) 2023. IN THE MEANTIME THE DEVICE WAS NOT USED. IT HAS BEEN CONFIRMED THAT NO PATIENT NOR OPERATOR GOT INVOLVED IN THIS EVENT. BASED ON THE AVAILABLE INFORMATION AND INVESTIGATION PERFORMED THE BREAKAGE OF THE FIBER HAPPENED RANDOMLY WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. ANYWAY, IT IS POSSIBLE TO SUPPOSE THAT THE BREAKAGE OF THE FIBER COULD HAVE BEEN CAUSED BY A MISHANDLE OF THE FIBE THAT HAS BEEN WRAPPED AROUND THE FIBER-BOOM WITH A VERY NARROW RADIUS, NOT IN ACCORDANCE WITH THE DEVICE'S OPERATOR'S MANUAL. NO DESIGN ISSUE NOR DEFICIENCY HAS BEEN IDENTIFIED AS CAUSE OF THE EVENT. THE RISK MANAGEMENT FILE OF THE DEVICE CODE RMF_M112X1_03 HAS BEEN EVALUATED FOR THE RISK RELATIVE TO UNWANTED LASER RADIATION DUE TO FIBER BREAKAGE AND FOUND STILL ADEQUATE. A REMEDIAL ACTION HAS BEEN PERFORMED IN DATE (B)(6) 2023: REPAIR OF THE DEVICE WITH REPLACEMENT OF THE OPTICAL FIBER. NO OTHER CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA IS REQUIRED: NO DESIGN DEFICIENCY IDENTIFIED AS ROOT CAUSE OF THE EVENT. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF A MALFUNCTION. GERMAN DISTRIBUTOR IN WHICH THEY INFORMED US OF AN EVENT IN WHICH THE AESTHETIC DEVICE MOTUS AX'S FIBER BROKE DURING A TREATMENT OF HAIR REMOVAL. THE ACTUAL DEVICE INVOLVED IS NOT A MEDICAL DEVICE BUT THE AESTHETIC DEVICE REF: M112D1 S/N:(B)(4). THE ACTUAL DEVICE INVOLVED IN THE EVENT IS NOT A MEDICAL DEVICE AND IS NOT MARKETED IN THE US. ANYWAY A SIMILAR, NOT IN THE INTENDED USE BUT RELATIVE TO HW ARCHITECTURE, MEDICAL DEVICE MOTUS AX WITH REF: M112B1 IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE US WITH 510(K) K162886. IN THE COMMUNICATION IT IS REPORTED THAT NO PATIENT OR OPERATOR GOT INJURED DURING THE EVENT. THE COMMUNICATION SENT BY THE DISTRIBUTOR ALSO SHARED SOME PICTURE OF THE LASER IN WHICH IT IS EVIDENT THAT THE BREAKAGE OF THE FIBER TOOK PLACE ABOUT 40CM FROM THE DEVICE-SIDE. THE 1200 UM OPTICAL FIBER ASSEMBLY IS EQUIPPED WITH AN EXTERIOR METAL SHIELDING IN ORDER TO MINIMIZE THE LASER RADIATION THAT COULD COME OUT IN THE EVENT OF A BREAKAGE. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN INITIALLY EVALUATED, BY AUTHORIZED LOCAL SERVICE, IN DATE FEBRUARY THE 28TH, 2022 IN WHICH THE DEVICE HAS BEEN FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS, EXCEPT FOR THE BROKEN FIBER. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON FEBRUARY THE 27TH 2023 BY SPECIFIC COMMUNICATION OF THE GERMAN DISTRIBUTOR, AND EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 1000-1040 THIS EVENT REPRESENT AN ARO (UNANTICIPATED LASER EMISSION) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630538 DEKA MOTUS AX DEKA MOTUS AX GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M112D1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown