MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM (BRAND NAME 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	01/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinic declined service inspection of the device, confirming this is an isolated incident.Investigation performed by inmode concluded that the reported burn was caused by a user error: the doctor utilized treatment parameters not congruent with the recommended protocol and delivered an excessive number of pulses to the region.Such excessive application of pulses was done on the same spot and apparently too superficially (incorrect technique), damaging completely the dermal plexus, leading to necrosis.Retraining has been scheduled for the doctor and inmode is monitoring patient's recovery.
Event or Problem Description
Full thickness burn with necrosis on submentum following quantum procedure.
Event or Problem Description
Full thickness burn with necrosis on submentum following quantum procedure.
Additional Manufacturer Narrative
The clinic declined service inspection of the device, confirming this is an isolated incident.Investigation performed by inmode concluded that the reported burn was caused by a user error: the doctor utilized treatment parameters not congruent with the recommended protocol and delivered an excessive number of pulses to the region.Such excessive application of pulses was done on the same spot and apparently too superficially (incorrect technique), damaging completely the dermal plexus, leading to necrosis.Retraining has been scheduled for the doctor and inmode is monitoring patient's recovery.On 30-mar-2026: fu report is submitted with additional informatino and corrections: b7 - corrected.H7 - updated.Although inmode has offered the doctor a full retraining, the doctor eventually declined it.The doctor received guidance from inmode's kol via phone/whatsapp.Inmode will continue to monitor patient's recovery.

• 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: 24545530
• Report Number: 3010511300-2026-01029
• Device Sequence Number: 5662570
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 02/09/2026
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2025
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Race: White