MAUDE Adverse Event Report: INMODE LTD FACETITE; RADIOFREQUENCY DEVICE

Model Number	AG609482A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In this case the platform that houses the handpiece was inspected since the hp was discarded after use.However, the morphology of the lesion suggests an excessive approach to the insertion port while delivering a quantum of energy towards the external surface to cause this type of full thickness burn.
Event or Problem Description
3rd degree burn developed following treatment with facetite, located in the central anterior area of the neck.The ablative lesion, rounded with a diameter of about 2 cm, appears decorticated of the dermis.Prophylactic medical intervention required to avoid secondary infection and facilitate wound healing.Scar formation cannot be ruled out at the moment.
Additional Manufacturer Narrative
Follow up report 07/03/2023.1.User error - an extremely excessive amount of energy administrated over the neck area (~16kj) compared to that foreseen by the protocol (~ 4 - 5 kj) and it also seems that the doctor went too close to the port of access during the retrograde maneuver.This caused a thermal lesion, developed internally in the subcutaneous tissue and vented externally.Investigation conclusions: excessive energy / heat accumulated and incorrect superficial maneuvering.2.Type of investigation code changed to 10.3.Added final test report and in service report (training summary).
Event or Problem Description
3rd degree burn developed following treatment with facetite, located in the central anterior area of the neck.The ablative lesion, rounded with a diameter of about 2 cm, appears decorticated of the dermis.Prophylactic medical intervention required to avoid secondary infection and facilitate wound healing.Scar formation cannot be ruled out at the moment.

• Brand Name: FACETITE
• Common Device Name: RADIOFREQUENCY DEVICE
• Manufacturer (Section D): INMODE LTD; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE MD; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 16953031
• Report Number: 3010511300-2023-00227
• Device Sequence Number: 3301300
• Product Code: GEI
• UDI-Device Identifier: 17290016633211
• UDI-Public: 17290016633211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182325
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Other,Notification,Patient Monitoring,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: AG609482A
• Device Catalogue Number: AG609482A
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White