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

Model Number	AG613237A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Full thickness (Third Degree) Burn (2696); Peripheral Nervous Injury (4414)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted following patient's report to fda.The patient, however, refused to provide contact details of the treatment provider.Inmode, therefore, could not conduct a thorough investigation of the complaint at this point.If additional information reaches us, a supplementary report will be submitted.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 69 year old female patient complained to fda about sustaining third degree burns on her submentum and neurapraxia of the marginal mandibular branch of the facial nerve, 1 month following treatment with quantum rf.
Event or Problem Description
A 69 year old female patient complained to fda about sustaining third degree burns on her submentum and neurapraxia of the marginal mandibular branch of the facial nerve, 1 month following treatment with quantum rf.
Additional Manufacturer Narrative
25-aug-2026: a supplementary report is being submitted with investigation conclusions.This case has been identified as a duplicate of another inmode's report (ref number: 3010511300-2026-01128), reported by the treatment provider (pa).Therefore, complaint 3010511300-2026-01128 was canceled in inmode's system and investigation conclusions are submitted as part of this follow-up report.The information provided by the pa matches the one provided by the patient, but without mentioning the neurapraxia (only the burns).The pa declined retraining and confirmed that the device works fine with no issues.The photos provided by the patient show two long full thickness burns spread over the submentum of ~4cm and 6 cm in length.On the photo of 11 days post tx the burns have a dry necrotic slough.According to the pa, patient was treated with silvadene, bacitracin, and doxycycline prophylactically.After that, the patient did not come for additional checkups.Treatment settings provided by the pa over the phone indicate an excessive energy delivery (excessive pulsing).The pa himself also acknowledged over the phone that such number of pulses exceeded the recommended protocol.Based on this information collectively, the root cause is attributed to a user error that most probably let to the reported thermal damage.The alleged neurapraxia was not mentioned by the pa in the phone call.However, based on our previous experience, such adverse event is caused by working too close to the facial nerve branches, contradictory to the ifu.Excessive pulsing on high energy was probably also a contributing factor.

• Brand Name: InMode RF system (brand name 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: 25133270
• Report Number: 3010511300-2026-01095
• Device Sequence Number: 8634747
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Consumer
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/10/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 112 LB
• Patient Race: White