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

Model Number	M122B1
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
In date 20/08/2025 we receive a communication from the us importer, cynosure, relative to a malfunction in which a clinic complaint of the device firing without any intervention (aro) 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 clinic sev lasers (usa) reported to the us importer that the device was firing without any intervention by the user.The us importer contacted the clinic which stated that no person were injured during the misfiring of the device.Cynosure, as us importer of the device, have already reported this case to the us fda with a dedicated mdr report code mdr1222993-2025-00028 in date august the 25th, 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.In date 06/08/2025 a us importer authorized technician proceeded to inspect the device and found that the fingerswitch cable is damaged.That said, he proceeded with the replacement of such cable and tested the device thoroughly.Following the cable replacement the device has been restored to working properly within specifications.The clinic confirmed, to the technician, that no person reported any injury during the event.It is not possible to exactly determine the root cause of the event while it is possible to hypothesize that the cable has worn-out due to usage of the device.Anyway, performed an analysis of previous similar cases recorded in the expected service life time-span (5 years) and found that the probability of occurrence of such event is 0.08%.That said no corrective action is deemed necessary for this case.Based on what reported above is possible to conclude that the most probable cause of the event is a worn-out of the component 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.

• 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: 23062207
• Report Number: 3001431138-2025-00007
• Device Sequence Number: 18604336
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)230309
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 08/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• 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
• Patient Sex: Unknown