BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYNOSURE CELLULAZE - SLT II

    MDR report key: 6275479 · Received January 25, 2017

    Report

    Report Number
    3001431138-2017-00001
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    December 19, 2016
    Report Date
    January 25, 2017
    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 FOR EVALUATION. US LOCAL AUTHORIZED SERVICE ((B)(4)) CHECKED THE ACTUAL SUSPECTED DEVICE UNIT AT CUSTOMER SITE ON BEHALF OF MANUFACTURER ON JANUARY 10TH, 2017. (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 (CYNOSURE'S SERVICE REPORT (B)(4)). TREATMENT PARAMETERS AND TECHNIQUE WERE NOT FOLLOWED PER CLINICAL GUIDELINES. THE USER DID NOT APPLY THE APPROPRIATE SETTINGS WITH REGARD TO THE PATIENT'S THIN SKIN (STRETCH MARKS/STRIAE) IN THE AFFECTED AREA. 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 (THE CAUSE OF THE EVENT IS COMMON TO ALL THE CASES RECORDED). IN FACT THE PHYSICIAN HAVE SET A TEMPERATURE VALUE OF THE THERMAGUIDE HIGHER THAN THE ONE STATED IN THE CLINICAL GUIDELINE IN REFERENCE TO THE SHALLOW TREATMENT AND THIN SKIN OF THE PATIENT . SCARRING AND SKIN AND FAT TISSUE NECROSIS ARE EXPECTED ADVERSE EFFECTS FROM LASER TREATMENTS TO THE ANATOMIC DISTRICT OF THE LASER PROCEDURE AS REPORTED BY SLT II OPERATOR MANUAL CODE OM094E1_G.V05 (REVISION VALID AT THE DATE OF EVENT) AT SECTION 9 "CLINICAL APPLICATIONS - ADVERSE EFFECTS". THE SAME ANTICIPATED ADVERSE EFFECTS ARE ALSO REPORTED IN THE CLINICAL REFERENCE GUIDE (CODE 921-7014-001), PROVIDED BY (B)(4) TOGETHER WITH THE DEVICE, AT CHAPTER 2 "CLINICAL APPLICATION - ADVERSE EFFECTS". MOREOVER, THE OPERATOR'S MANUAL 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. NO FAILURE DETECTED ON THE ACTUAL DEVICE EVALUATED. DEVICE WORKING WITHIN SPECS. NO REMEDIAL ACTIONS REQUIRED. MANUFACTURER'S INVESTIGATION ON THIS EVENT CONFIRMS THE RESULT OF THE PREVIOUS INCIDENTS (DEVICE IS WORKING PROPERLY WITHIN SPECIFICATIONS AND THE ROOT CAUSE OF THE ADVERSE EVENT IS AN ERROR OF THE PHYSICIAN TO PROPERLY USE THE DEVICE IN REFERENCE TO WHAT STATED ON THE OPERATIVE MANUAL AND CLINICAL GUIDELINES) INVOLVING THE SAME DEVICE UNIT AT THE SAME CLINIC, HAPPENED ON (B)(6) 2012 AND (B)(6) 2014, MANAGED WITH (B)(4) MDR REPORTS # 3001431138-2016-00001 AND #3001431138-2016-00002. 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

    US IMPORTER'S CYNOSURE INC. NOTICED US ABOUT AN ADVERSE EVENT THEY RECENTLY BECAME AWARE OF. INVOLVED DEVICE IS CYNOSURE CELLULAZE - SLT II MODEL NUMBER M094E1, S/N (B)(4), MANUFACTURED BY (B)(4). A FEMALE PATIENT (AGE (B)(6) AT THE TIME OF THE EVENT) SUFFERED A BURN ON THE ABDOMEN REGION WHICH RESULTED IN SCARRING FROM A LASER ASSISTED LIPOSUCTION PROCEDURE WITH THE DEVICE. PATIENT WAS PRESCRIBED MEDICATION FOR PREVENTIVE CASE USE: PERCOCET AND KEFLEX AND RECEIVED MEDICAL ATTENTION FROM A BURN CENTER. THIS INCIDENT WAS CLASSIFIED AS A REPORTABLE EVENT BY THE US IMPORTER BECAUSE PATIENT RECEIVED MEDICAL INTERVENTION AND DEVELOPED SCARRING. THE US IMPORTER, (B)(4), SUBMITTED AN MDR INITIAL REPORT TO FDA FOR THIS EVENT (# 1222993-2017-00008) ON JANUARY 23RD, 2017 . (B)(4). ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR (B)(4). THE ACTUAL DATE OF THE EVENT IS (B)(6) 2016. EVENT TOOK PLACE IN THE US TERRITORY AT (B)(6). THIS EVENT REPRESENT A THIRD INCIDENT INVOLVING THE SAME DEVICE UNIT (SERIAL NUMBER (B)(4)) AT THE SAME CUSTOMER SITE ((B)(6)) AND WITH SIMILAR INJURY SUFFERED BY DIFERENT PATIENTS. PREVIOUS EVENTS OCCURRED, RESPECTIVELY, ABOUT FOUR YEARS AND HALF AGO (EVENT DATE (B)(6) 2012) AS REFERENCED IN THE (B)(4) MDR REPORT # 3001431138-2016-00001 (AND CORRESPONDING US IMPORTER MDR REPORT # 1222993-2015-00058) AND ABOUT TWO AND A HALF YEARS AGO (EVENT DATE (B)(6) 2014) AS REFERENCED IN THE (B)(6) MDR REPORT # 3001431138-2016-00002 (AND CORRESPONDING US IMPORTER MDR REPORT # 1222993-2016-00001). WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON 01/13/2016 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58311 CYNOSURE CELLULAZE - SLT II CYNOSURE CELLULAZE - SLT II GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M094E1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention