MAUDE Adverse Event Report: INMODE LTD. Ignite RF Pro system (brand name Luxora) with Quantum handpiece; GEI

Model Number	AG613238A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinic did not provide the completed clinical form.However, the clinic declined service inspection for the device and disclosed they intentionally treated this patient with excessive energy, which, combined with incorrect technique led to the burn.A retraining has been scheduled for the clinic and inmode is monitoring patient's recovery.
Event or Problem Description
A male patient presenting with a full thickness burn on his right submentum following quantum 10 treatment.
Event or Problem Description
A male patient presenting with a full thickness burn on his right submentum following quantum 10 treatment.
Additional Manufacturer Narrative
27-july-2026: follow-up report is submitted with corrections and additional information.Device details were corrected in the fields:d1.D4.Additional information: the clinic did not provide the completed clinical form.The clinic declined service inspection for the device and the offered retraining.The treatment provider disclosed they intentionally treated this patient with excessive energy, which, combined with incorrect technique led to the burn.No updated information on patient's recovery could be obtained since the clinic became non-responsive.

• Brand Name: Ignite RF Pro system (brand name Luxora) with Quantum handpiece
• Common Device Name: GEI
• Manufacturer (Section D): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 25344628
• Report Number: 3010511300-2026-01100
• Device Sequence Number: 18701808
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K240780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Other,Notification,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AG613238A
• Device Catalogue Number: AG613238A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/31/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White