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

Model Number	AG604881A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cellulitis (1768); Full thickness (Third Degree) Burn (2696)
Date of Event	03/06/2024
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 temperatures and total energy that exceeded the recommended limits per ifu.This was combined with incorrect technique: stamping on the same spot for too long and not having a good control of the internal probe, leading to full depth thermal injury.Secondary infection is attributed to lack of aseptic conditions during/post procedure.Retraining has been scheduled for the clinic.The patient is currently being treated with laser for scars at the same clinic.
Event or Problem Description
Full thickness burns on medial thighs, with secondary infection, post bodytite procedure.

• Brand Name: BODYTITE PRO 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: 20234934
• Report Number: 3010511300-2024-00646
• Device Sequence Number: 12752840
• Product Code: GEI
• UDI-Device Identifier: 07290016633368
• UDI-Public: 07290016633368
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K233642
• 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,Inspection,Notification,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: AG606972A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2020
• 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: 39 YR
• Patient Sex: Female
• Patient Race: White