DEKA LIPOAI
Report
- Report Number
- 3001431138-2025-00005
- Event Type
- Injury
- Date Received
- August 4, 2025
- Date of Event
- June 12, 2025
- Report Date
- August 4, 2025
- Manufacturer
- EL.EN. ELECTRONIC ENGINEERING S.P.A.
- Product Code
- GEX
- UDI-DI
- 08057017760580
- PMA / PMN Number
- K212270
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
WE AS MANUFACTURER OF THE DEVICE INVOLVED IN THE EVENT PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION SHARED BY THE US IMPORTER. THE US IMPORTER AND OUR CLINICAL DEPARTMENT HAVE EVALUATED ALL THE AVAILABLE INFORMATION AND CONCLUDED THE FOLLOWING: THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED IN DATE JULY THE 8TH, 2025 BY (B)(6) AUTHORIZED TECHNICIAN AND FOUND WORKING PROPERLY WITHIN SPECIFICATIONS. DURING THE TECHNICAL INSPECTION THE PATIENT'S FOLDER HAS BEEN RETRIEVED BY THE TECHNICIAN IN WHICH A SCREEN SHOT OF THE PARAMETERS USED HAS BEEN FOUND. IN SUCH DOCUMENT IT IS CLEAR THAT THE AI MODE (MOVEMENT CONTROL WITH ACCELEROMETER) WAS DISABLED. ALL THE AVAILABLE DATA HAS BEEN FORWARDED TO OUR CLINICAL RESEARCH AND PRACTICE MANAGER IN ORDER TO HAVE AN EVALUATION OF THE EVENT. HIS CONCLUSIONS ARE THE FOLLOWING: THE PARAMETERS USED FOR THE TREATMENT WERE VERY AGGRESSIVE WITH A TOTAL AMOUNT OF ENERGY DELIVERED ALMOST 5 TIMES HIGHER THAN THE SUGGESTED. MOREOVER, THE DISABLING OF THE AI MODE (ACCELEROMETER) COULD HAVE CONTRIBUTED TO THE EVENT IN THE LIGHT OF THE LOCATION OF THE BURNS. SCARRING, ESPECIALLY IN CASE OF USE OF HIGH LEVEL OF ENERGY, ARE IDENTIFIED AS A FORESEEABLE SIDE EFFECT OF THE TREATMENT AS REPORTED IN THE DEDICATED CHAPTER OF THE OPERATOR'S MANUAL CODE OM131A1_G.V02 (ACTUAL REVISION SHIPPED WITH THE DEVICE). BASED ON WHAT REPORTED ABOVE THE ROOT CAUSE OF THE EVENT HAS BEEN IDENTIFIED AS A USER ERROR IN WHICH THE PHYSICIAN USED TOO MUCH AGGRESSIVE PARAMETERS. BASED ON WHAT REPORTED ABOVE IS POSSIBLE TO CONCLUDE THAT THE MOST PROBABLE CAUSE OF THE EVENT IS A USER ERROR (TREATMENT PERFORMED WITH TOO MUCH AGGRESSIVE PARAMETERS) AND THAT NO DESIGN ISSUES HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT. THE PRESENT MDR REPORT IS CONSIDERED AS A FINAL REPORT UNLESS FDA HAS MORE QUESTIONS ABOUT IT.
IN DATE JULY THE 9TH 2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, (B)(6) RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BURNS ON THE CHEST FOLLOWING A LASER LIPOLYSIS TREATMENT WITH THE DEVICE LIPO AI. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS A LIPO AI, MANUFACTURED BY (B)(6) ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K212270. THE US IMPORTER, IN THE NARRATIVE AND INVESTIGATION PROVIDED WITH THE EVENT, REPORTED THE FOLLOWING: THE TREATMENT WAS PERFORMED IN DATE (B)(6) 2025. THE PARAMETERS USED FOR THE TREATMENT WERE 4887 JOULES DELIVERED ON EACH SIDE. 300MJ AND 40HZ (12 POWER AND LOW WERE LISTED ON THE OP NOTES). IT IS REPORTED THAT GLANDS HAVE BEEN REMOVED MANUALLY. PICTURES OF THE PATIENT WERE TAKEN THE DAY AFTER THE TREATMENT SHOWED SOME DARKENING UNDER THE TAPE. 4 DAYS AFTER TREATMENT THE PATIENT REMOVED THE TAPING THAT REVEALED FULL THICKNESS BURNS. IMMEDIATELY AFTER THE TREATMENT THE AREA WAS NOT FOUND WARM OR HOT. AS POST TREATMENT CARE THE PATIENT WAS INSTRUCTED TO NOT USE ANY GARMENT. WE, THE MANUFACTURER OF THE DEVICE, EVALUATED THE EVENT AS REPORTABLE UNDER 21 CFR PART 803 DUE TO THE FACT THAT THE LESION REPORTED BY THE PATIENT ARE CONSIDERED SERIOUS INJURIES (FULL THICKNESS BURNS) THAT MAY REQUIRE MEDICAL ATTENTION TO PREVENT A PERMANENT IMPAIRMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1584908 | DEKA LIPOAI | DEKA LIPOAI | GEX | EL.EN. ELECTRONIC ENGINEERING S.P.A. | M131A1 | 08057017760580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |