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

Model Number	AG613237A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient treated with quantum 25 and morpheus8 on the same session on her abdomen.According to the treatment provider, "no bleeding, pain, or incident during or immediately after procedure." were noted.Three days post procedure, the patient informed the treatment provider that she's been "aggressively massaging llq and felt "pop" and kept doing it.".Although advised by the provider to avoid these actions, the patient continued "to try to "milk" the area from incision.".The treatment provider suspected a seroma.Fifteen days post tx, patient's husband informed the treatment provider that "the client was hospitalized due to hematoma".The hematoma was drained on the 6th day in the hospital and the patient was released on day 10.At day 38 post tx, the patient's status is stable.
Additional Manufacturer Narrative
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 is performing investigation of this incident and will submit a supllementary report once additional information becomes available.
Additional Manufacturer Narrative
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 is performing investigation of this incident and will submit a supllementary report once additional information becomes available.09-apr-2026: follow up report is submitted with additional information and investigation concslusions: h6 - was updated.No technical issues were identified in the system upon inspection.In a more recent call the user confirmed there was no seroma and the patient was only treated for hematoma at the hospital.Investigation concluded that the vigorous massage done by the patient herself likely led to a vessel breaking and bleeding, and subsequently to hematoma.Although there was no user error, retraining was offered to the clinic, but the customer became non-responsive.
Event or Problem Description
A female patient treated with quantum 25 and morpheus8 on the same session on her abdomen.According to the treatment provider, "no bleeding, pain, or incident during or immediately after procedure." were noted.Three days post procedure, the patient informed the treatment provider that she's been "aggressively massaging llq and felt "pop" and kept doing it.".Although advised by the provider to avoid these actions, the patient continued "to try to "milk" the area from incision.".The treatment provider suspected a seroma.Fifteen days post tx, patient's husband informed the treatment provider that "the client was hospitalized due to hematoma".The hematoma was drained on the 6th day in the hospital and the patient was released on day 10.At day 38 post tx, the patient's status is stable.

• 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: 24187560
• Report Number: 3010511300-2026-01009
• Device Sequence Number: 18604632
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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 Practitioner
• Remedial Action: Patient Monitoring,Notification,Inspection,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Race: White