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

Model Number	AG613237A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Peripheral Nervous Injury (4414)
Date of Event	01/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Technical inspection of the system involved revealed no technical issues.The temporal relationship and anatomical proximity of the access point to neural structures support a reasonably possible causal relationship to the procedure.The reported neuropathy is attributed to incorrect technique used by the doctor.A retraining is planned.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 female patient complained about neuropathic pain radiating along the ulnar nerve 5 days following the quantumrf procedure on her arms.Patient is currently on pregabalin & vit b complex.
Additional Manufacturer Narrative
17-feb-2026: follow up report is submitted with updated information: b5 event description has been updated.Investigation conclusions updated: technical inspection of the system involved in the incident revealed no technical issues.The reported neuropathy is attributed to incorrect technique used by the doctor.The doctor worked in proximity to the ulnar nerve, contrary to the ifu.This was further aggravated by delivering total energy that exceeds the recommended protocol to the treatment area, not suitable for the given patient.Per latest update, the patient has completely recovered.Proper technique and avoidance of high-risk anatomical areas have been dicussed with the doctor and additional retraining has been scheduled for the doctor.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 female patient complained about neuropathic pain radiating along the ulnar nerve 5 days following the quantumrf procedure on her arms.Patient was prescribed pregabalin, vitamin b complex, and short-course prednisolone.

• Brand Name: IGNITE RF SYSTEM 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: 24143704
• Report Number: 3010511300-2026-01005
• Device Sequence Number: 18513405
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Inspection,Other,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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: Female
• Patient Race: Asian