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
Additional Manufacturer Narrative
We as manufacturer of the device have performed our own investigation based on the information gathered by the us importer from the clinic.A technician inspected the device in date july the 3rd, 2024.The device was found to be working properly without any issue and within specifications.As a precautionary measure the technician proceeded to replace the foot pedal.Ordinary maintenance and full check on the device was performed afterwards.Due to the fact that the device was found to be working properly it was not possible to determine the root cause of the event.The replaced foot pedal has been requested, despite being found correctly working, to be shipped back for analysis.In case the investigation on this component will change the root cause of the event, a dedicated follow-up report will be promptly submitted with the gathered information.Moreover, the event is mitigated in its potential risk due to the fact that the emission, with failure of the foot-pedal can only took place with the device in ready-mode which required the operator, patient and all other person present within the device's room to wear the appropriate safety goggles.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 or Problem Description
On july the 19th, 2024, el.En.Electronic engineering spa received a communication from the us importer cynosure of a malfunction, with the device elite iq, in which the customer complaints of the device double pulsing and footswitch working intermittently.The actual device involved in the event is an elite iq laser medical device (ref: m122b1, s/n: (b)(6)) that is marketed in the us with 510(k) number k193426 in the above-mentioned communication is reported the following: cynosure reported that the clinic was complaining about the device in which the foot pedal did not work properly and sometimes double pulses.In the communication is reported that no patient nor operator reported any injury due to this malfunction.The event took place at the look lab placed in (b)(6).The present event has been evaluated as a reportable due to the fact that the event represent an accidental radiation occurrence (aro).Moreover, the us importer, cynosure, proceeded to submit their own mdr report code mdr1222993-2024-00040 in date july the 26th, 2024.We the manufacturer of the device proceeded to submit our own mdr report, in accordance with 21 cfr part 803.50(2) in order to supply any missing information.

• 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: 19916993
• Report Number: 3001431138-2024-00014
• Device Sequence Number: 20856753
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)211102
• 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: 505
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: Health Professional
• Device Model Number: M122B1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2021
• 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