MAUDE Adverse Event Report: INMODE LTD. IGNITE RF WITH QUANTUM RF; GEI

Model Number	AG613237A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
05-mar-2026: follow-up report is submitted with updated information.D1 - updated.D4 - updated.Up to date the clinic remained non-responsive to inmode's requests to provide the relevant clinical information and no photos/clinical form have been received.Due to clinic's non-responsiveness, inmode could not inspect the device and no retraining was scheduled.Although the reported description most probably corresponds to a transient neurapraxia, due to lack of information the exact root cause cannot be established.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 treatment provider reported of a female patient with "a nerve affected under her mouth" following treatment with quantum 10.According to the provider "it's been several weeks.".
Additional Manufacturer Narrative
Up to date the clinic remained non responsive to inmode's requests to provide additional information and no photos/clinical form have been received.Investigation is ongoing and supllementary report will be submitted once additional information becomes available.
Event or Problem Description
A treatment provider reported of a female patient with "a nerve affected under her mouth" following treatment with quantum 10.According to the provider "it's been several weeks.".

• Brand Name: IGNITE RF WITH QUANTUM RF
• 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: 23860321
• Report Number: 3010511300-2025-00995
• Device Sequence Number: 4706433
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Inspection,Patient Monitoring,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 11/22/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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 Sex: Female