MAUDE Adverse Event Report: INMODE LTD. IGNITE RF SYSTEM WITH BODYTITE HANDPIECE; GEI

Model Number	AG613237A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Necrosis (1971); Full thickness (Third Degree) Burn (2696)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A full thickness burn with necrosis at the navel of a female patient following procedure that included liposuction, followed by bodytite and morpheus8.
Additional Manufacturer Narrative
Preliminary investigation has concluded that the burn is not related to morpheus8 due to it superficial fractional mechanism of action, whereas it is attributed to the invasive rfal technology.The location of the burn points to a user error who went back too close to the incision port, contrary to the ifu.Additionally, since bodytite procedure was performed following liposuction, less aggressive settings should have been used as per inmode's recommended protocols.Final conclusions are pending technical inspection of the device.Inmode will submit a supplementary report once additional information becomes available.Per latest update, the burn has healed, with slight deformation of the navel and pigmentation.A retraining has been scheduled for the clinic.This report is submitted in compliance with fda regulations at 21 cfr part 803 and should not be considered to be an admission that any inmode product is defective or caused serious injury.On 25-mar-2026: fu report is submitted with investigation conclusions.The device was inspected and it was revealed that the internal temperature channel was not performing as intended.However, technical investigation concluded that this could not have led to the reported burn since thermal monitoring remained fully active through the external electrode sensor that functioned properly.Any abnormal temperature elevation would therefore trigger the system's safety mechanism, resulting in automatic interruption of rf energy delivery.The root-cause of the reported burn was therefore attributed to incorrect technique combined with aggressive treatment settings not suitable for the given adipose layer.Specifically, the user persistently went back to the incision port, contrary to the ifu while using a very high cut-off temperature not congruent with the recommended protocol.Customer was retrained.Per latest update, the burn has healed, with slight deformation of the navel and pigmentation.
Additional Manufacturer Narrative
Preliminary investigation has concluded that the burn is not related to morpheus8 due to it superficial fractional mechanism of action, whereas it is attributed to the invasive rfal technology.The location of the burn points to a user error who went back too close to the incision port, contrary to the ifu.Additionally, since bodytite procedure was performed following liposuction, less aggressive settings should have been used as per inmode's recommended protocols.Final conclusions are pending technical inspection of the device.Inmode will submit a supplementary report once additional information becomes available.Per latest update, the burn has healed, with slight deformation of the navel and pigmentation.A retraining has been scheduled for the clinic.This report is submitted in compliance with fda regulations at 21 cfr part 803 and should not be considered to be an admission that any inmode product is defective or caused serious injury.
Event or Problem Description
A full thickness burn with necrosis at the navel of a female patient following procedure that included liposuction, followed by bodytite and morpheus8.

• Brand Name: IGNITE RF SYSTEM 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: 24387056
• Report Number: 3010511300-2026-01020
• Device Sequence Number: 10240511
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Inspection,Patient Monitoring,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: White