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	Difficulty Chewing (4522); Muscle/Tendon Damage (4532)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During training with the device, the doctor performed tunneling (prior to rf delivery), causing an intense pain in the patient.Although up to date no additional clinical information has been received from the clinic to fully assess the reported injury, inmode concluded that it was caused by a user error, specifically working aggressively at incorrect plane/depth, possibly causing damage to the muscle.The incorrect technique was addressed on spot by inmode trainer.Per latest update, patient has improved.If inmode becomes aware of any additional information that might affect the investigation conclusions, a supplementary report will be submitted.
Event or Problem Description
10 days post procedure, a clinic reported of a patient sustaining possible muscle damage during usage of quantum 10, while the doctor was performing tunneling (without rf delivery).The patient was being treated aggressively on his right side of the face and apparently the doctor moved too deep with the device causing intense pain in the patient.Later, the patient reported intense pain during chewing.

• 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: 25298081
• Report Number: 3010511300-2026-01098
• Device Sequence Number: 21211585
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Remedial Action: Notification,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male