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

Model Number	AG604881A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Scar Tissue (2060); Full thickness (Third Degree) Burn (2696)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Technical inspection of the system did not reveal any technical issues.The handpiece was not inspected as it was discarded by the user.Investigation attributed the root cause to user errors: the doctor utilized cut off temperature and total energy that exceeded the recommended limits per ifu.This was combined with incorrect technique: heating on moving forward, stamping on the same spot for too long and not having a good control of the handpiece depth.This has led to the thermal injury, which later resulted in scars.Retraining has been scheduled for the clinic.Patient is being treated for scars at the same clinic.
Event or Problem Description
Burns on thighs and scarring 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: 20489781
• Report Number: 3010511300-2024-00659
• Device Sequence Number: 4209030
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring,Other,Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 10/20/2024

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
• Date Returned to Manufacturer: 10/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Race: White