MAUDE Adverse Event Report: EL.EN. ELECTRONIC ENGINEERING S.P.A. DEKA SMARTXIDE2

Model Number M103F1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

We, the manufacture of the device, evaluated the present adverse event not reportable to the us fda due to the fact that a similar device is marketed in the us (deka smartxide2) but it differs substantially because the rf accessory is not cleared for the us market.That said it is impossible to have a similar event (burns caused by rf treatment) in the us territories.The patient's lesion has been caused while using the dot+rf scanner and the burns can be attributed to the rf part of the treatment.The similar device marketed in the us did not bear the dot+rf scanner.In fact, the dot+rf scanner is not cleared by any 510(k) and the similar device's intended use did not concern the rf treatment but only the co2.Based on that, we evaluated the event not reportable to the us fda.Such approach has been shared with the us importer, cynosure inc., that - anyway - proceeded to submit the reports mdr1222993-2023-00019 and mdr1222993-2023-00020 to the us fda.At the contrary to what reported on their mdr reports, we were not made aware of their submission.We became aware of cynosure's report only on january the 24, 2024 during our periodic review of the reports present on the maude database.Once we became aware of this, we proceeded to prepare and submit the present report in order to update any information missing on the importer's report (in accordance with us fda 21 cfr part 803.50(b)(2)).The delay of this report, related to our awareness date of this event, is only due to the fact that we evaluated the event as not reportable to us fda.Here below the results of our investigation: we the manufacturer of the device performed our own investigation by gathering information form the clinic and performing the evaluation of the actual medical device involved in the event.The actual device involved in the event has been inspected in date december the 27th, 2023 by local authorized service technician.The technician found the device working properly within specifications.The clinical data available, relative to the treatment performed on the patient, has been evaluated by el.En.'s clinical department manager who evaluated the parameters used and found them on the aggressive side.Moreover, it is not possible to establish if the physician performed overlapping with the rf forks nor if he made a proper contact of them to the skin during the treatment.Based on the available information is possible to determine that the most probable cause of the event is a user error of the physician that have not made a proper contact between rf forks and patient's skin and could have done some overlapping.No design deficiency has been found to be contributory to the event.No corrective action/preventive action/fsca is required.The present initial report has to be considered as a final report unless fda has further questions.

Event Description

On (b)(6) 2023, el.En.Electronic engineering spa received a communication from the chinese distributor in which they reported of a case in which two patients developed burns following a treatment with the laser medical device smartxide2.In the initial communication it has been reported that the treatment was performed with the dot+rf scanner on the face.Pictures of the patient's lesion has been disclosed within the first communication of the event while more detailed information about the treatment's parameters has been disclosed after.By the images provided it is evident that the lesion reported by the patient has been caused by the rf part of the dot+rf treatment.We, the manufacturer of device, became aware of the event on (b)(6), 2023 by specific communication of the chinese distributor, and evaluated the event as not reportable, according to fda 21 cfr 803 due to the fact that a device with a similar technology as the one that caused the event (rf treatment) is not made available on the us territories by el.En.Electronic engineering.Despite that, our us importer (cynosure inc.- head company of the chinese distributor - cynosure china) proceeded to report 2 dedicated mdr report to the fda (mdr 1222993-2023-00019 and mdr 1222993-2023-00020), one for each of the patient involved in the adverse event.More detail on the event is reported in section h10 of the present report.

• Brand Name: DEKA SMARTXIDE2
• Type of Device: DEKA SMARTXIDE2
• 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, firenze 50041 ; IT 50041
• Manufacturer Contact: andrea checchi ; via baldanzese 17; calenzano, firenze 50041 ; IT 50041
• MDR Report Key: 18573743
• MDR Text Key: 333659990
• Report Number: 3001431138-2024-00001
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08034108510466
• UDI-Public: (01)08034108510466(11)220720
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M103F1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other