MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM (BRAND NAME IGNITE RF) WITH FACETITE; GEI

Model Number	AG613237A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Nerve Damage (1979); Full thickness (Third Degree) Burn (2696)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Female patient sustained full thickness burn on her jowl and facial neurapraxia following rfal procedure.Investigation is ongoing.
Event or Problem Description
Full thickness burn on jowl and facial neurapraxia following rfal procedure.
Additional Manufacturer Narrative
Female patient sustained full thickness burn on her jowl and facial neurapraxia following rfal procedure.Investigation is ongoing.On 03-aug-2025: a follow-up report is submitted with corrections and investigation conclusions: g2 was corrected (foreign was added).Technical inspection of the system revealed no technical issues.Investigation concluded that the neurapraxia was caused by working in the "no fly" zone, close to the branches of the facial nerve.The burns were caused by incorrect technique: applying rf at the same spot for too long, rubbing against the dermal plexus.
Event or Problem Description
Full thickness burn on jowl and facial neurapraxia following rfal procedure.

• Brand Name: INMODE RF SYSTEM (BRAND NAME IGNITE RF) WITH FACETITE
• 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: 21959431
• Report Number: 3010511300-2025-00823
• Device Sequence Number: 20639873
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2025
• Supplement Date Received by Manufacturer: 04/20/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White