MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM (BRANDNAME IGNITE RF) WITH QUANTUM HANDPIECE; GEI

Model Number	AG613237A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Necrosis (1971); Full thickness (Third Degree) Burn (2696)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During investigation it was revealed that the doctor has not been previously trained by inmode on this device.No technical issues were found with the system upon inspection (the probe was discarded by the user and therefore not inspected).Multiple user errors were determined to be the cause of this adverse event (incorrect treatment parameters and incorrect technique): the doctor utilized energy levels exceeding the recommended range, pulsing excessively on the same spot and working too superficially, damaging the dermal plexus, which eventually led to the burn and the necrosis.Training has been scheduled for the doctor and inmode continues to monitor patient's healing.
Event or Problem Description
Full thickness burns with necrosis on the jawline following quantum procedure.

• Brand Name: INMODE RF SYSTEM (BRANDNAME IGNITE RF) 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: 23388652
• Report Number: 3010511300-2025-00935
• Device Sequence Number: 12368159
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Remedial Action: Patient Monitoring,Notification,Inspection,Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: AG613237A
• Device Catalogue Number: AG613237A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White