BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYNOSURE CELLULAZE - SLT II

    MDR report key: 6033199 · Received October 17, 2016

    Report

    Report Number
    3001431138-2016-00008
    Event Type
    Injury
    Date Received
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K123407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER'S FOR EVALUATION. US LOCAL AUTHORIZED SERVICE ENGENEER ((B)(4)) CHECKED THE ACTUAL SUSPECTED DEVICE UNIT AT CUSTOMER SITE ON BEHALF OF MANUFACTURER ON SEPTEMBER 20TH, 2016. (B)(4) SERVICE TECHNICIAN EVALUATED THE DEVICE FOR CALIBRATION AND PERFORMANCE OF LASER AND ACCESSORIES. THE CELLULAZE-SLT II UNIT AND RELEVANT ACCESSORIES WERE DETERMINED TO BE OPERATING PROPERLY WITHIN THEIR SPECIFICATIONS. NO FAILURE DETECTED ((B)(4)). TREATMENT PARAMETERS, USED BY THE PHISICIAN AT THE TIME OF THE EVENT, WERE NOT MADE AVAILABLE BY THE PHISICIAN. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY OR DEVICE MALFUNCTIONING WAS RESPONSIBLE FOR CAUSING THE EVENT. RATHER, IT COULD BE ASSUMED THAT THERE WAS A HUMAN FACTORS ISSUE, WHERE A FAILURE TO PROPERLY USE THE DEVICE, CONTRIBUTED TO THE EVENT. THE OPERATOR MANUAL CODE OM094E1_G.V05 (ACTUAL REVISION SHIPPED WITH THE DEVICE) IN SECTION 8 'CLINICAL APPLICATION', FOR ALL THE TREATMENT FOR WICH THIS DEVICE IS INTENDED, REPORTS THAT SCARS ARE FORSEEABLE SIDE EFFECTS OF THE TREATMENT. HYPERPIGMENTATION CAN BE MEANT AS AN EXPECTED EVOLUTION OF SCARRING. SAME SIDE EFFECTS ARE REPORTED ALSO IN (B)(4) CLINICAL REFERENCE GUIDE FOR ALL THE TREATMENT FOR WHICH THE DEVICE IS INTENDED. NO FAILURE DETECTED IN THE ACTUAL DEVICE EVALUATED. DEVICE WORKING WITHIN SPECS. BASED ON THAT, NO REMEDIAL ACTIONS ARE REQUIRED. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    (B)(4), NOTICED US ABOUT AN ADVERSE EVENT THEY RECENTLY BECAME AWARE OF. INVOLVED DEVICE WAS CYNOSURE CELULAZE - SLT II MODEL NUMBER M094E1, S/N (B)(4), MANUFACTURED BY (B)(4). THE ACTUAL DATE OF EVENT IS UNKNOWN AND CYNOSURE INC. BECAME AWARE OF THIS INCIDENT ON SEPTEMBER 14TH, 2016. EVENT TOOK PLACE IN THE UNITED STATES TERRITORY AT (B)(6). (B)(4) CLINICAL INVESTIGATOR COLLECTED INFORMATION FROM CUSTOMER AND INFORMED US THAT ONE CYNOSURE CELULAZE - SLT II LASER WAS INVOLVED IN A LASER TREATMENT ON PATIENT WHO DEVELOPED KELOID SCARRING AND HYPERPIGMENTATION ON TIGHTS. PATIENT WAS TREATED AFTER THE TREATMENT WITH 4% HYDROQUINONE AND KENALOG INJECTIONS/SILICONE SHEETING. CYNOSURE INC, HAVE SUBMITTED AN MDR REPORT, CONCERNING THIS EVENT ON (B)(6) 2016, (B)(4) FOR THE CYNOSURE CELLULAZE - SLT II DEVICE AS IMPORTER. WE, THE MANUFACTURER OF DEVICE CYNOSURE CELULAZE - SLT II, BECAME AWARE OF THE EVENT ON OCTOBER 3RD, 2016 BY EMAIL FROM (B)(4). SUBMITTED TO FDA AN OWN INITIAL 30 DAYS MDR REPORT. THIS EVENT IS REPORTABLE TO FDA, ON THE SIDE OF CAUTION, BECAUSE THE INJURIES (KELOID SCARRING AND HYPERPIGMENTATION) TO PATIENT FALLS UNDER THE DEFINITION OF 'SERIOUS INJURY' AND BECAUSE THEY REQUIRED A MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684697 CYNOSURE CELLULAZE - SLT II ND: YAG LASER GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M094E1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other