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

Model Number	AG604881A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinic reported of a female patient sustaining full thickness burn on her arm post bodytite procedure.Investigation is ongoing.
Event or Problem Description
Full thickness burn on arm post bodytite procedure.
Additional Manufacturer Narrative
Clinic reported of a female patient sustaining full thickness burn on her arm post bodytite procedure.Investigation is ongoing.(b)(6) 2025: follow up report is submitted with investigation conclusions.Technical inspection of the system revealed no issues (the probe was discarded by the user and therefore not inspected).Investigation attributed the root cause to user errors: the doctor used aggressive treatment parameters not congruent with the recommended protocol (excessive cut-of temperatures and total energy), combined with incorrect technique and treatment area.
Event or Problem Description
Full thickness burn on arm 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: 21372426
• Report Number: 3010511300-2025-00751
• Device Sequence Number: 8598718
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other,Notification,Patient Monitoring,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: White