BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYNOSURE CELLULAZE - SLT II

    MDR report key: 5387636 · Received January 25, 2016

    Report

    Report Number
    3001431138-2016-00002
    Event Type
    Injury
    Date Received
    January 25, 2016
    Date of Event
    December 22, 2014
    Report Date
    January 25, 2016
    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

    (B)(4). 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 (CYNOSURE'S SERVICE (B)(4)). TREATMENT PARAMETERS USED BY PHYSICIAN WERE WITHIN CLINICAL GUIDELINES. SINCE THIS EVENT TOOK PLACE ABOUT ONE YEAR AGO ON (B)(6) 2014, THE AUTHORIZED SERVICE VERIFIED THAT THERE IS NO PENDING ISSUE WITH THE SLT II DEVICE. IT WAS LAST CHECKED IN (B)(6) 2015 WITHOUT ANY PROBLEMS SINCE THEN (CYNOSURE SERVICE REPORT IS (B)(4) DATED (B)(6) 2015). MOREOVER, SINCE THE LAST SERVICE VISIT, THE UNIT IS CORRECTLY WORKING WITHOUT ANY PENDING ISSUE. BECAUSE OF THIS, THERE WAS NO FURTHER SERVICE REPORT CREATED. CURRENTLY, NO ADDITIONAL SERVICE VISIT OR DEVICE RETURNING IS REQUIRED FOR THIS EVENT. 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. 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 "CLINICA L APPLICATIONS - ADVERSE EFFECTS". THE SAME ANTICIPATED ADVERSE EFFECTS ARE ALSO REPORTED IN THE CLINICAL REFERENCE GUIDE (CODE 921-7014-001), PROVIDED BY CYNOSURE 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 INCIDENT INVOLVING THE SAME DEVICE UNIT AT THE SAME CLINIC, HAPPENED ON (B)(6) 2012, MANAGED WITH EL.EN. 'S MDR REPORT # 3001431138-2016-00001. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    (B)(4). A FEMALE PATIENT ((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: TRIAZOLOM, PHENERGAN, AND KEFLEX AND WAS MONITORED BY SITE DOCTOR ON MULTIPLE FOLLOW UP APPOINTMENTS. NO OTHER INFORMATION WAS MADE AVAILABLE BY THE CUSTOMER SITE REGARDING TREATMENT PARAMETERS/DETAILS OF THE EVENT. THE PATIENT IS NOW DOING WELL, BUT 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) REPORT TO FDA FOR THIS EVENT (# 1222993-2016-00001) ON (B)(4). THIS ADVERSE EVENT ACTUALLY OCCURRED ON (B)(6) 2014, MORE THAT ONE YEAR AGO, BUT US IMPORTER BECAME AWARE OF THIS INCIDENT ON (B)(6) 2015 AFTER PATIENT HAD RECENTLY GONE TO A NEWS CREW/PRESS "PRESS/NEWS CREW" TO SHARE EXPERIENCE ABOUT THE CUSTOMER SITE. THIS EVENT REPRESENT A SECOND INCIDENT INVOLVING THE SAME DEVICE UNIT (SERIAL NUMBER (B)(4)) AT THE SAME CUSTOMER SITE (LASER AESTHETICS BODY AND WELLNESS" - (B)(4) US) AND WITH SIMILAR INJURY SUFFERED BY A DIFFERENT PATIENT. PREVIOUS EVENT OCCURRED ABOUT TWO YEARS AND HALF BEFORE THE FIRST ONE (EVENT DATE (B)(6) 2012) AS REFERENCED IN THE EL.EN. 'S MDR REPORT # 3001431138-2016-00001 (AND CORRESPONDING US IMPORTER MDR REPORT # 1222993-2015-00058). WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 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
    47106 CYNOSURE CELLULAZE - SLT II ND: YAG LASER OYW EL.EN. ELECTRONIC ENGINEERING S.P.A. M094E1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability