BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYNOSURE CELLULAZE - SLT II

    MDR report key: 5309549 · Received December 18, 2015

    Report

    Report Number
    3001431138-2015-00003
    Event Type
    Injury
    Date Received
    December 18, 2015
    Date of Event
    October 29, 2015
    Report Date
    December 18, 2015
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    OYW
    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 FOR EVALUATION. US LOCAL AUTHORISED SERVICE (CYNOSURE INC. PERSONNEL) CHECKED THE ACTUAL SUSPECTED DEVICE UNIT AT CUSTOMER SITE ON BEHALF OF MANUFACTURER ON (B)(6) 2015. CYNOSURE 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 (SERVICE REPORT N° S65807). TREATMENT PARAMETERS USED BY PHYSICIAN WERE WITHIN CLINICAL GUIDELINES. 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 APPROPRIATELY USE THE DEVICE, CONTRIBUTED TO EVENT. PRECISION TX DELIVERY SYSTEM, AN ACCESSORY TO DELIVER OPTICAL ENERGY FOR CELLULAZE-SLT II 1440NM WAVELENGTH LASER, IS INDICATED FOR ABLATION AND COAGULATION OF SOFT TISSUE, SUCH AS SKIN, CUTANEOUS AND SUBCUTANEOUS TISSUE AND GLANDS, AND LASER ASSISTED LIPOLYSIS OF SMALL AREAS. THE PATIENT WAS SUBMITTED TO PRECISION TX TREATMENT WHICH REQUIRES THE INTRODUCTION OF THE CANNULA TROUGH A 1MM INCISION ON PATIENT SKIN. THE LOWER FACE-NECK REGION IS ALLOWED AS TREATMENT AREA FOR THE DEVICE INTENDED USE, BUT THIS AREA IS CRITICAL FOR THE PRESENCE OF MANDIBULAR NERVES, AND CAUTION SHOULD BE OBSERVED DURING TREATMENT TO AVOID ADVERSE EVENTS RELATED TO NERVE INJURY. CLINICAL REFERENCE GUIDE (CODE 921-7019-000), PROVIDED BY CYNOSURE TOGETHER WITH THE DEVICE, SPECIFICALLY REQUIRES (CHAPTER 5 - "NECK CONTOURING") TO PROCEED WITH THE PATIENT MARKING OF THE AREA TO BE TREATED AVOIDING MANDIBULAR LINE. THE MARKING OF THE LOCATION OF MANDIBULAR NERVE IS ALSO REQUIRED TO THE PHYSICIAN SO THAT IT MAY BE AVOIDED DURING THE PROCEDURE. MOREOVER, CLINICAL REFERENCE GUIDE REFERS TO OTHER CLINICAL LITERATURE TO BE CONSULTED FOR MORE INFORMATION AS "FACIAL DANGER ZONE, AVOIDING NERVE INJURY IN FACIAL PLASTIC SURGERY", ALERTING THE USER ABOUT CRITICAL TREATMENT AREA. THE OPERATOR'S MANUAL (CODE OM094E1_G.V12) SPECIFIES (SECTION 1 - "INTRODUCTION") THAT THIS DEVICE IS INTENDED FOR THE USE BY A LICENSED PRACTITIONER WITH EXPERIENCE IN THE FIELD OF LIPOSUCTION AND LIPOLYSIS TREATMENTS. THE OPERATOR'S MANUAL INCLUDES ALSO (SECTION 8 -" CLINICAL APPLICATIONS - PRECISION TX ADVERSE EVENT") A CAUTION TO MAINTAIN THE FIBER IN A HORIZONTAL PLANE TO MINIMIZE UNINTENTIONALLY DELIVERY OF ENERGY TO THE SKIN AND UNDERLYING STRUCTURES. THE PATIENT NOW STILL HAVE SOME WEAKNESS OF MENTALIS NERVE. HOWEVER, THE PATIENT IS CONTINUING TO HAVE FOLLOW UP APPOINTMENTS WITH THE DOCTOR TO ADDRESS THIS ADVERSE EFFECT. US IMPORTER INFORMED US THAT LATEST UPDATE INVOLVES PATIENT IS NOW DOING WELL/HEALING. DEVICE WORKING WITHIN SPECS. NO REMEDIAL ACTIONS REQUIRED. EL.EN. ELECTRONIC ENGINEERING (B)(4), MANUFACTURER OF THE DEVICE, NEVER RECORDED SIMILAR ADVERSE EVENT BEFORE, COMPARED TO MORE THAN SEVEN HUNDRED UNITS INSTALLED ON THE FIELD FROM 2011 TO DATE AND THOUSANDS OF TREATMENTS PERFORMED. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS. EVALUATION PERFORMED BY LOCAL SERVICE.

    Description of Event or Problem · 1

    THE US IMPORTER REPORTED US ABOUT AN ADVERSE EVENT INVOLVING THE DEKA SLT II MEDICAL LASER DEVICE, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4). A PATIENT (FEMALE, (B)(6)) DEVELOPED A WEAK MENTALIS NERVE FOLLOWING A ND:YAG LASER PRECISION TX TREATMENT WITH DEKA SLT II DEVICE ON LOWER FACE-NECK REGION. PATIENT WAS IN THE TRENDELENBURG POSITION DURING TREATMENT. PATIENT SOUGHT MEDICAL INTERVENTION TO ADDRESS THIS ISSUE. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE BY THE USER FACILITY REGARDING POST CARE TREATMENT DETAILS. EVENT OCCURRED AT (B)(6). THE ACTUAL DATE OF EVENT IS (B)(6) 2015. (B)(4). WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2015 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803.50(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. THIS EVENT IS REPORTABLE BECAUSE THE PATIENT RECEIVED MEDICAL INTERVENTION. US IMPORTER INFORMED US THAT PATIENT CONTINUES TO HAVE FOLLOW UP VISIT WITH DOCTOR. LATEST UPDATE INVOLVES PATIENT IS NOW DOING WELL/HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836358 CYNOSURE CELLULAZE - SLT II ND: YAG LASER OYW EL.EN. ELECTRONIC ENGINEERING S.P.A. M094E1

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention