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	Hematoma (1884); Thrombosis/Thrombus (4440); Muscle/Tendon Damage (4532)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Female patient was hospitalized due to hematoma and abdominal muscle damage following liposuction procedure (with non inmode device) and procedure with inmode handpiece.Investigation is ongoing.
Event or Problem Description
Hematoma amd damage to abdominal muscles following liposuction procedure, followed by treatment with quantum 25 handpiece.
Additional Manufacturer Narrative
Female patient was hospitalized due to hematoma and abdominal muscle damage following liposuction procedure (with non-inmode device) and procedure with inmode handpiece.Investigation is ongoing.(b)(6) 2025: fu report is submitted to update the following: b5 (event description) has been updated.Investigation conclusions: the incident occurred at the door w4 facility.However, the door w4 only provided the hall for the training workshop that took place prior to this incident and are not responsible for this incident.The treatment was performed on inmode's employee after the closure of the training workshop for other devices.Dr.(b)(6) (gmc (b)(4)) who was never trained to use inmode devices, first performed a liposuction procedure with a vacuum syringe with fat aspiration cannula (a non inmode device), and then quantum procedure on the abdomen of inmode employee.The procedures were done under guidance of dr.(b)(6) (gmc (b)(4)), who, although being inmode's kol at the time of the event, was not authorized nor trained to use inmode's quantum devices.Additionally, this patient could not serve as a candidate for these procedures due to a very thin adipose layer on her abdomen.The patient was anesthetized only locally and during the liposuction procedure she repeatedly pleaded to stop due to an acute pain, despite which the doctors continued the procedure.A third doctor, dr.(b)(6) (gmc (b)(4)), was also present during this event but was not physically taking part in it.Although the reported damage is most probably attributable to the aggressive and incorrectly performed liposuction done with the syringe and the cannula, we cannot exclude the involvement of inmode device in this incident.Performing such a procedure without proper credentials and compliance measures represents gross malpractice and a violation of medical ethics.The patient, while being inmode's employee, acted against company's policy by providing an unapproved device to untrained and unauthorized healthcare professionals.The employee volunteered for a procedure after the closure of the official workshop and without being a proper candidate for such procedure.Inmode has conducted multiple internal remedial and preventative actions following this incident.
Event or Problem Description
Hematoma, muscle damage and blood clots following liposuction procedure (with a non-inmode device), followed by treatment with inmode quantum 25 device.

• 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: 21458574
• Report Number: 3010511300-2025-00773
• Device Sequence Number: 7591461
• Product Code: GEI
• UDI-Device Identifier: 07290019863076
• UDI-Public: 07290019863076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White