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

Model Number	AG613237A
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Swelling/ Edema (4577)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted following a report submitted to fda (report number mw5176553) by the treating clinic, which reported the following physical effects related to a quantum rf procedure: blistering, persistent swelling, burning sensation and pain, visible scarring at multiple entry points, skin discoloration / pigmentation changes, loose skin and uneven cosmetic results, and sedation/ drowsiness (patient reported sleeping from evening through morning).The device was inspected and no technical issues were identified.The initially reported burn was attributed to incorrect technique, whereas the edema was considered a labeled expected side effect for an invasive procedure.The additionally claimed burning sensation, pain and scarring at entry points - all are expected side effects associated with an invasive procedure, listed in device's labeling.Scarring at the entry points is considered an expected trivial effect associated with an invasive procedure, especially considering the information provided in the clinical form stating that the incision was made with 18g needle, and the photos on which the entry port does not exceed 5mm.Inmode does not have adequate information to assess the cause or extent of pigmentation changes, loose skin, and uneven cosmetic results.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.Inmode has provided all relevant information known to the company as of the submission date of this report and will file a supplemental report if additional relevant information becomes known.
Event or Problem Description
Burn on arm and edema on braline following quantum 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: 23446959
• Report Number: 3010511300-2025-00872
• Device Sequence Number: 9040207
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other,Inspection,Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 11/02/2025

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: 07/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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 Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White