MAUDE Adverse Event Report: INMODE LTD. INMODE RF WITH BODYTITE HANDPIECE; GEI

Model Number	AG604881A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Necrosis (1971); Full thickness (Third Degree) Burn (2696)
Date of Event	07/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Necrosis post full thickness burn near the knee post bodytite procedure.
Additional Manufacturer Narrative
Investigation is ongoing.
Additional Manufacturer Narrative
The clinic declined technical inspection of the device and did not provide exact treatment settings used in the procedure.The doctor acknowledged her user error.Investigation attributed the root cause to incorrect technique: stamping on the same spot for too long (instead of pulsing at withdrawal) and rubbing the probe against the dermal plexus, leading to the observed thermal damage and necrosis.The doctor has received a retraining.
Event or Problem Description
Necrosis post full thickness burn near the knee post bodytite procedure.

• Brand Name: INMODE RF WITH BODYTITE 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: 22949818
• Report Number: 3010511300-2025-00891
• Device Sequence Number: 9893941
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151793
• 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,Other,Patient Monitoring,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2025

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: AG604881A
• Device Catalogue Number: AG606969A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• 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: Required Intervention; Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: White