MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM (BRANDNAME IGNITE RF) WITH BODYTITE 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	05/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient sustaining a full thickness burn with necrosis on the right medial brachial region (few cm above the elbow) following treatment with bodytite.
Additional Manufacturer Narrative
Investigation concluded that the reported adverse event is attributed to user errors.Specifically, the access port was not done in the recommended location, which did not enable good access to the brachial region.Additionally, judging by the close location of the burn to the incision port, the doctor was persistently going back too close to it, staying there and pulsing excessively, damaging the dermal plexus and leading to the necrosis.The user errors were addressed with inmode clinical team.The case was subsequently escalated to inmode's kol for urgent consultation, and recommendations were provided.Inmode will continue to monitor patient's recovery.

• Brand Name: INMODE RF SYSTEM (BRANDNAME IGNITE RF) WITH BODYTITE 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: 25606118
• Report Number: 3010511300-2026-01112
• Device Sequence Number: 5533718
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K251254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Patient Monitoring,Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: AG613237A
• Device Catalogue Number: AG613237A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/24/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian