MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING S.P.A. ELITE IQ

Model Number	M122B1
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In date (b)(6) 2025 we receive a communication from the us importer, cynosure, relative to an adverse event in which a patient developed burns following a hair removal treatment, on the legs, with the device elite iq.The actual device involved in the event is an elite iq, manufactured by el.En.Electronic engineering spa, marketed in the usa with 510(k) k193426.The event took place at (b)(6).The patient complained with the clinic about burs that have developed on the treatment area (legs) following the hair removal treatment.The us importer, following the initial communication, proceed to gather more detailed information about the event.The operator who performed the treatment admitted that the patient went to a vacation in (b)(6) and the treatment area was still tanned.Operator reported to have started the treatment with the yag laser source then changed to alex.Alex laser source is not the proper wavelength to be used on darker skin types (such as tanned skin).Parameters used for the treatment were: alex laser source (755 nm), 15j/cm2, 20ms with 18mm handpiece with one pass.The patient was prescribed with biafine cream as preventative post-treatment care.Pictures of the lesion were also disclosed in which it is clear that the patient developed blistering and burns on the area with the worst effects on the shin.The pictures has been reviewed by both the us importer's clinical staff as well as ours (as manufacturer of the device).The lesion has been evaluated as a serious injury because they may require medical attention to prevent a permanent impairment.Cynosure, as us importer of the device, have already reported this case to the us fda with a dedicated mdr report code mdr1222993-2025-00051 in date october the 29th, 2025.Based on that, in accordance with 21 cfr part 803.50(b)(2) we as manufacturer of the device are obliged to submit our own report to the fda.
Additional Manufacturer Narrative
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 medical device involved in the event has been evaluated by cynosure's authorized technician, in date 17/10/2025 and found working properly within specifications.The us importer concluded that the event has been caused by a user error where the physician used treatment's parameters not adequate in relation to the patient's conditions.All the available information has been evaluated by our crp manager who concluded the following: he agrees with the conclusion made by the us importer, in relation to the root cause, where the event has been caused by a user error in which the physician have not used the proper treatment's parameters.The operator's manual, code om122b1-d1_g.V07 (actual revision shipped with the device) clearly identifies patient that have recent sun exposure as contraindicated for the treatment (chapter 'contraindications').Burns are clearly identified as foreseeable side effects of the treatment on the operator's manual, code om122b1-d1_g.V07 (actual revision shipped with the device) at chapter 'adverse effects'.The root cause identified as a user error in which the physician failed to evaluate the patient's condition and proceeded by treating a tanned area.Based on the investigation carried out no design issues of malfunction has been found to be contributory to the event.That said, no actions has been deemed necessary.The present mdr report is considered as a final report unless fda has more questions about it.

• Brand Name: ELITE IQ
• Common Device Name: ELITE IQ
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, firenze 50041 ; IT 50041
• Manufacturer (Section G): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese, 17; calenzano, firenze 50041 ; IT 50041
• Manufacturer Contact: andrea checchi ; via baldanzese, 17; calenzano, firenze 50041 ; IT 50041
• MDR Report Key: 23643346
• Report Number: 3001431138-2025-00011
• Device Sequence Number: 10099872
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)221020
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K193426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: M122B1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female