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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cellulitis (1768); Salivary Gland Problem (4484)
Date of Event	01/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation points to a user error: working in the wrong plane damaging the parotid gland.Final conclusions are pending results of technical inspection of the device.Supplementary report will be submitted upon completion of investigation.
Event or Problem Description
A doctor reported to inmode about a 62-year-old female patient treated with quantum rf on her lower face and jowls, diagnosed with parotitis with infection.Patient was admitted to the hospital and started on iv antibiotics, received a dose of iv steroids.Incision and drainage have been performed with persistent re-accumulation of fluids.~1 week later, the patient was injected 30 units of botox directly into the parotid gland and started on glycopyrrolate orally for salivary gland suppression.
Event or Problem Description
A doctor reported to inmode about a 62 year-old female patient treated with quantum rf on her lower face and jowls, diagnosed with parotitis with infection.Patient was admitted to the hospital and started on iv antibiotics, received a dose of iv steroids.Incision and drainage have been performed with persistent re-accumulation of fluids.~1 week later, the patient was injected 30 units of botox directly into the parotid gland and started on glycopyrrolate orally for salivary gland suppression.
Additional Manufacturer Narrative
19-may-2026: a follow-up report is submitted with additional information and investigation conclusions.The system passed technical inspection with no findings.The treatment provider operated in the wrong plane injuring the parotid gland.Although treatment parameters were within the recommended protocol, the thermal component likely acted as an additional contributing factor, as it does not require significant energy to injure the parotid duct or its branches when the device is positioned incorrectly.The customer received a retraining.Inmode could not obtain an updated information regarding patient's recovery as the customer became non-responsive.

• 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: 24574705
• Report Number: 3010511300-2026-01036
• Device Sequence Number: 9434855
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Notification,Patient Monitoring,Other,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White