MAUDE Adverse Event Report: INMODE LTD. INMODE RF; GEI

Model Number	AG604881A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No technical issues were found in the system during service inspection.Hp was not returned for inspection.The investigation attributed the root cause to user errors: cut off temperatures used were above the recommended per ifu and obviously too high for the given thin fat layer.The technique also appears to be incorrect:poor control of treatment depth and of the hp movement.The doctor declined a retraining.
Event or Problem Description
Full thickness burn on jowl.
Additional Manufacturer Narrative
No technical issues were found in the system during service inspection.Hp was not returned for inspection.The investigation attributed the root cause to user errors: cut off temperatures used were above the recommended per ifu and obviously too high for the given thin fat layer.The technique also appears to be incorrect: poor control of treatment depth and of the hp movement.The doctor declined a retraining.(b)(6) 2024: correction is submitted to correct h10 (manufacturer narrative).Handpiece name was added.The handpiece involved in the incident was facetite.No technical issues were found in the system during service inspection.Hp was not returned for inspection.The investigation attributed the root cause to user errors: cut off temperatures used were above the recommended per ifu and obviously too high for the given thin fat layer.The technique also appears to be incorrect: poor control of treatment depth and of the hp movement.The doctor declined a retraining.
Event or Problem Description
Full thickness burn on jowl.

• Brand Name: INMODE RF
• 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: 19788435
• Report Number: 3010511300-2024-00575
• Device Sequence Number: 8303019
• Product Code: GEI
• UDI-Device Identifier: 07290016633016
• UDI-Public: 07290016633016
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/19/2024

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: AG604881A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/21/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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