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

Model Number	AG613237A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Necrosis (1971); Full thickness (Third Degree) Burn (2696)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor provided a photo of a female patient allegedly treated with quantum rf during the training conducted in his clinic in (b)(6) 2025, where a full thickness burn with necrosis can be seen on the right jawline, protruding to the lower neck.No additional information was provided by the doctor and no clinical form was received with treatment details.Upon reviewing the in-service report for this training, no treatment was done on such patient in this area with this handpiece.Additionally, the doctor contacted inmode 3 days after the training and stated, "training on saturday went well and all worked well", without reporting any adverse event.The device was inspected following doctor's phone call, due to the doctor complaining about a technical issue not enabling treatments.The technical issue identified during service inspection was not related to the quantum rf handpiece.The provided photo's creation date was 10 days after the training, and 1 day after the device was already picked up from the clinic for service inspection.The device was inspected for a second time with no issues identified.Additionally, the vast necrosis observed on the photo is not typical of quantum technology due to its various safety mechanisms and controlled treatment pattern.All in all, investigation cannot unequivocally establish a causal relationship between the reported lesion and quantum handpiece, nor to establish the root-cause due to lack of information.A follow up report will be submitted if additional significant information will be received.
Event or Problem Description
Full thickness burn with necrosis situated on the right jawline, allegedly following quantumrf procedure.

• 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: 23642363
• Report Number: 3010511300-2025-00896
• Device Sequence Number: 15992614
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/25/2025
• 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; Required Intervention
• Patient Sex: Female
• Patient Race: White