MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING S.P.A. DEKA SMARTXIDE WITH DOT SCANNER

Model Number	M079R1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypopigmentation (4838)
Date of Event	11/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, el.En.Electronic engineering spa became aware of an adverse event via email from the patient in which she complaints of hypopigmentation on the neck and face following a co2 fractional laser treatment.In the initial communication received from the patient it is not specified the actual medical device involved in the event but the patient just supposed that the device was a smartxide.Patient reported that the event took place in date (b)(6) 2022 at (b)(6) in (b)(6).Based on the information reported on the patient's communication we proceeded by contacting the clinic in order to gather more detailed information on the event and to identify the actual device involved in the event.The device has been identified as a deka smartxide with dot scanner (ref: m079r1 - s/n: (b)(6) - udi: (b)(4) manufactured by el.En.Electronic engineering spa ad marketed in the usa with 510(k) number k072159.We, the manufacturer of device, became aware of the event on october the 18th, 2023 by email from the patient and, according to 21 cfr part 803 evaluated the event reportable because we have assumed the lesions to be a permanent impairment (on the side of caution).
Additional Manufacturer Narrative
We, the manufacturer of the device performed the investigation by contacting the clinic and the physician who performed the treatment on the patient.We contacted the clinic where the treatment was performed and the actual device involved in the event.In fact, the actual device involved in the event has been identified as a deka smartxide with dot scanner with serial number (b)(6) that is marketed in the us with 510(k) number k072159.We requested more detailed information to the physician of the clinic who performed the treatment, dr.(b)(6), who stated to have not heard anything from the patient ever since the treatment and to not being aware of any complaint from her.No more information about the vent have been disclosed from the physician.The event took place at (b)(6) clinic placed at (b)(6) - usa.The actual device involved in the event, has not been checked due to the fact that almost a year has passed since the date of the event (as reported by the patient on her communication) and because the user never reported of device's failures and/or alarm that arose in this year.The user kept using the device normally without any issue.No remedial action required - investigation on the event resulted impossible, based on the available information.Anyway, in case of new information will be made available for this case a follow-up to this report will be submitted in a timely manner.This initial report is to be considered as final report, unless fda has further questions.

• Brand Name: DEKA SMARTXIDE WITH DOT SCANNER
• Common Device Name: DEKA SMARTXIDE WITH DOT SCANNER
• Manufacturer (Section D): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese 17; calenzano, 50041 ; IT 50041
• Manufacturer (Section G): EL.EN. ELECTRONIC ENGINEERING S.P.A.; via baldanzese, 17; calenzano, 50041 ; IT 50041
• Manufacturer Contact: andrea checchi ; via baldanzese, 17; calenzano, firenze 50041 ; IT 50041
• MDR Report Key: 18132959
• Report Number: 3001431138-2023-00011
• Device Sequence Number: 18071243
• Product Code: GEX
• UDI-Device Identifier: 08057017760078
• UDI-Public: (01)08057017760078(11)220210
• Combination Product (Y/N): N
• PMA/510(K) Number: K072159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2023

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: Health Professional
• Device Model Number: M079R1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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