MAUDE Adverse Event Report: INMODE LTD BODYTITE; INMODE RF SYSTEM

Model Number	AG606969A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Left posterior upper arm burned while using bodytite technology.
Additional Manufacturer Narrative
Third-degree burn (full thickness) located in the postero-medial aspect of the left arm, approximately 3 x 2 cm in size.The event occurred in (b)(6) 2022 and is only now being reported.Following the use of the bodytite in various positions and in both supine and prone decubitus.The patient was subsequently treated with 5 sessions of laser over the scar area.The last documented follow-up session dates back to (b)(6) 2022 where the issue has not been resolved.Although at present the patient would in all likelihood have recovered and largely healed; however, not having the photos of the current state and in consideration of the entity of the event (third degree burn) it was decided to report the case to the competent authorities.
Event or Problem Description
Left posterior upper arm burn while using bodytite technology.
Additional Manufacturer Narrative
Follow up 07/02/2023.1.Investigation conclusions : user error excluding technical failure and being the setting of parameters in accordance with the protocol, it is a question of a wrong maneuvering, approaching too close to the port of access and lingering too long while the energy was being supplied.Summary of related investigations: excess of energy in the surface area due to incorrect movement technique with the cannula.2.Medical device problem code - changed to 2017.3.Type of investigation - changed to 10.4.Investigation findings - changed to 4248.5.Investigation conclusions - changed to 61.6.Added section g1.

• Brand Name: BODYTITE
• Common Device Name: INMODE RF SYSTEM
• Manufacturer (Section D): INMODE LTD; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 0; IS 206920
• Manufacturer (Section G): INMODE LTD; 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: 16597458
• Report Number: 3010511300-2023-00207
• Device Sequence Number: 14582337
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• 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): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Notification,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2023

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: AG606969A
• Device Catalogue Number: AG606969A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 07/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White