BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYNOSURE CELLULAZE - SLT II

    MDR report key: 5379126 · Received January 20, 2016

    Report

    Report Number
    3001431138-2016-00001
    Event Type
    Injury
    Date Received
    January 20, 2016
    Date of Event
    May 24, 2012
    Report Date
    January 20, 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

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. US LOCAL AUTHORIZED SERVICE ((B)(4) PERSONNEL) CHECKED THE ACTUAL SUSPECTED DEVICE UNIT AT CUSTOMER SITE ON BEHALF OF MANUFACTURER ON JANUARY 19TH 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 ((B)(4) SERVICE REPORT (b)(4)). TREATMENT PARAMETERS USED BY PHYSICIAN WERE WITHIN CLINICAL GUIDELINES. SINCE THIS EVENT TOOK PLACE ABOUT 3.5 YEARS AGO ON 05/24/2012, THE AUTHORIZED SERVICE VERIFIED THAT THERE IS NO PENDING ISSUE WITH THE SLT II DEVICE. IT WAS LAST CHECKED IN JANUARY 2015 WITHOUT ANY PROBLEMS SINCE THEN ((B)(4) SERVICE REPORT IS (b)(4) DATED 01/19/2015). 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 "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. EL.EN. ELECTRONIC ENGINEERING S.P.A., MANUFACTURER OF THE DEVICE, RECORDED ONLY ONE SIMILAR EVENT BEFORE, COMPARED TO MORE THAN (B)(4) UNITS INSTALLED ON THE FIELD WORLDWIDE FOR SLT II FAMILY MODELS FROM 2008 TO DATE AND TENS OF THOUSANDS OF TREATMENTS PERFORMED. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    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 S.P.A. - (B)(4). A FEMALE PATIENT ((B)(6) AT THE TIME OF THE EVENT) DEVELOPED SCARRING ON HER CHEST-ABDOMEN AREA FROM A LASER LIPOSUCTION PROCEDURE WITH THE DEVICE. PATIENT THEN REQUIRED MEDICAL INTERVENTION FROM THE ONSITE DOCTOR AND WAS PRESCRIBED KEFLEX AND LORTAB FOR HEALING CARE. PATIENT HAS NOT BEEN SEEN BY THE CUSTOMER SITE (LASER TREATMENT CLINIC) SINCE 2012. DUE TO THE MEDICAL INTERVENTION RECEIVED BY THE PATIENT AND EXPECTED SCARRING AND PERMANENT INJURY FROM THIS EVENT, SO THIS INCIDENT WAS CLASSIFIED AS A REPORTABLE EVENT BY THE US IMPORTER. THE US IMPORTER, (B)(4), SUBMITTED AN MDR INITIAL REPORT TO FDA FOR THIS EVENT (B)(4) ON 12/28/2015. (B)(4). ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING S.P.A. MEDICAL DEVICES. THE EVENT OCCURRED AT (B)(6). THIS ADVERSE EVENT ACTUALLY TOOK PLACE ABOUT 3.5 YEARS AGO ON (B)(6) 2012, BUT (B)(4) BECAME AWARE OF THIS INCIDENT ON 11/30/2015. PATIENT HAD RECENTLY SHARED HER EXPERIENCE TO A "PRESS/NEWS CREW" REGARDING THE CUSTOMER SITE (LASER TREATMENT CLINIC). FROM THIS, (B)(4) WAS THEN MADE AWARE. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON 12/28/2015 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39568 CYNOSURE CELLULAZE - SLT II ND: YAG LASER OYW EL.EN. ELECTRONIC ENGINEERING S.P.A. M094E1

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability