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

Model Number	AG613237A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Neuropathy (1983)
Type of Reportable Event	Serious Injury
Event or Problem Description
A doctor reported of 3 patients presenting with neuropathy symptoms (persistent, daily tingling and shooting pain in the arms and thighs) following treatment combining liposuction with quantum 25.This complaint is for patient #1.
Additional Manufacturer Narrative
Up to date the doctor has not provided any photos nor filled the clinical form.Inmode is performing investigation and will submit a supllementary report once additional information becomes available.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 doctor reported of 3 patients presenting with neuropathy symptoms (persistent, daily tingling and shooting pain in the arms and thighs) following treatment combining liposuction with quantum 25.This complaint is for patient #1.
Additional Manufacturer Narrative
25-may-2026: follow up report is submitted following investigation.Up to date the doctor has been non-responsive to inmode's attempts to obtain additional clinical information and to the offers to inspect the device or receive a retraining.No conclusions could be drawn with regards to the root cause of the alleged adverse events.If inmode becomes aware of additional information that might impact the conclusions of the investigation, a supplementary report wil be submitted.

• Brand Name: INMODE RF SYSTEM (BRANDNAME 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: 24924529
• Report Number: 3010511300-2026-01061
• Device Sequence Number: 10299660
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other,Inspection,Notification,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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: Unknown