MAUDE Adverse Event Report: EL. EN. ELECTRONIC ENGINEERING SPA ELITE IQ

Model Number	M122B1
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power from the laser energy was painful while using elite iq.Site confirmed no patient injury occurred.Technician found the handpiece delivering low energy >20% out of specification.Due to the energy operating out of the specification range, this event is an aro (accidental radiation occurrence) and therefore reportable.

• Brand Name: ELITE IQ
• Common Device Name: ELITE IQ
• Manufacturer (Section D): EL. EN. ELECTRONIC ENGINEERING SPA; via baldanzese 17; calenzano, 50041 ; IT 50041
• MDR Report Key: 15052736
• Report Number: 1222993-2022-00028
• Device Sequence Number: 5500767
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)211119
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2022
• Report Date (Section F): 07/19/2022

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
• Device Catalogue Number: 105-7041-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/20/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/30/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/19/2022