BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYNOSURE SMARTLIPO MPX

    MDR report key: 9564088 · Received January 8, 2020

    Report

    Report Number
    3001431138-2020-00001
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    September 18, 2019
    Report Date
    January 8, 2020
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K080121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. US IMPORTER'S AUTHORIZED SERVICE PERSONNEL CHECKED THE ACTUAL DEVICE UNIT AT CUSTOMER SITE ON NOVEMBER 21ST, 2019. THE TECHNICIAN FOUND, PRIOR TO ANY SERVICING OPERATION, THE DEVICE TO BE WORKING PROPERLY WITHIN SPECIFICATIONS ((B)(4)). THE DEVICE PARAMETERS FOR THE TREATMENT OF THE PATIENT ARE THE FOLLOWING: FLUENCE 1: 2500 J/CM2 WITH PULSE DURATION 'BLEND 3'; FLUENCE 2: 4300 J/CM2 WITH PULSE DURATION 'BLEND 6'. THE AFOREMENTIONED SETTING ARE RELATED FOR DEEP TREATMENT THAT ARE NOT RECOMMENDED IN THE CLINICAL REFERENCE GUIDELINES (CRG - 921-7014-001). IN FACT IN THE CRG THE ONLY RECOMMENDED TREATMENT FOR THE NECK IS 'SHALLOW' WITH BLEND 1. THAT SAID IS POSSIBLE TO CONCLUDE THAT THE PARAMETER USED WERE TOO MUCH AGGRESSIVE RELATED TO THE TREATMENT AREA (NECK). ANYWAY IN THE OPERATOR MANUAL CODE OM094A1_G.V06 (ACTUAL REVISION SHIPPED WITH THE DEVICE) SCARRING IS IDENTIFIED A FORESEEABLE SIDE EFFECT IN CHAPTER "ADVERSE EFFECTS". 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 EVENT HAS BEEN CAUSED BY A HUMAN FACTOR ISSUE IN WHCIH THE OPERATOR FAILED TO PROPERLY SET THE PARAMETERS OF TREATMENT IN RELATION TO THE TREATMENT AREA (USER ERROR) 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 DECEMBER 11TH, 2019, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY US IMPORTER, (B)(4) IN WHICH IT IS REPORTED THAT A PATIENT SUFFERED OF LONGER HEALING TIME AND RISK OF SCAR TISSUE FOLLOWING A TREATMENT WITH SMARTLIPO MPX LASER MEDICAL DEVICE. BASED ON THE INFORMATION PROVIDED BY THE US IMPORTER, THAT CONTACTED DIRECTLY THE PHYSICIAN WHO PERFORMED THE TREATMENT, DR. (B)(6), THE PATIENT HAS BEEN TREATED ON THE NECK AND SUFFERED A LONG TIME FOR HEALING. BASED ON THE ANALYSIS OF THE PATIENT DEVELOPED SCAR TISSUE AND IS PRESCRIBED WITH KENALOG TO POST TREAT. (B)(4) ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. (B)(4) IDENTIFIED THE ACTUAL DEVICE INVOLVED IN THE EVENT AS A SMARTLIPO MPX LASER MEDICAL DEVICE SERIAL NUMBER # (B)(4), REF #M094A1 MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA. COMPANY PLACED IN (B)(4). THE ACTUAL INVOLVED MEDICAL DEVICE IS INSTALLED AT (B)(6), US.(B)(4) COMPANY LOCATED IN (B)(4) US SUBMITTED AN MDR INITIAL REPORT TO FDA FOR THIS EVENT (#(B)(4)) ON DECEMBER THE 11TH, 2019. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON DECEMBER THE 11TH, 2019 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 CONDUCT AN INVESTIGATION OF THE EVENT AND TO OBTAIN MISSING OR INCOMPLETE INFORMATION PROVIDED BY THE IMPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28940 CYNOSURE SMARTLIPO MPX CYNOSURE SMARTLIPO MPX GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M094A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other