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

Catalog Number	105-7041-000
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
It was reported by the customer site that the elite iq was firing without operator touching the handpiece or pressing on the footpedal.No patient injury was reported.Field service engineer (fse) arrived at the site and restarted the device.The device restarted and relayed a message for the operator to release the foot pedal.The operator was not touching the foot pedal, but message still appeared.To resolve the issue, fse replaced the electrical fiber cable.Due to the site reporting unintended discharges of laser energy, 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: 19391758
• Report Number: 1222993-2024-00028
• Device Sequence Number: 7772278
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)211119
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/24/2024
• Report Date (Section F): 05/24/2024

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: Other
• Device Catalogue Number: 105-7041-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• 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: 05/24/2024