MAUDE Adverse Event Report: INMODE LTD. BodyTite Pro; GEI

Model Number	AG606972A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Necrosis (1971)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Incision ports on abdomen and flanks not healing 10 months post procedure that combined liposuction and bodytite.According to the patient, after he complained to the doctor that the incisions were not closing, he was treated with antibiotics and drainage attempt was performed.8 months post tx he received steroids injections into each incision port.The patient also reported contour irregularity near his navel which is attributed to an excessive liposuction, not related to the bodytite device.
Additional Manufacturer Narrative
No technical issues were revealed upon system inspection.Although the doctor did not provide photos/ccq, the case was investigated based on the photos provided by the patient.It appears the doctor persistently went back too close to the incision ports while pulsing, which led initially to an extensive thermal damage at the incision ports.This in turn led to the observed necrosis which prevents the healing.The root cause was established to be an incorrect technique, not congruent with the ifu.Per latest update, the patient turned to another clinic for excision revision.

• Brand Name: BodyTite Pro
• 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: 50471481
• Report Number: 3010511300-2026-01141
• Device Sequence Number: 10241393
• Product Code: GEI
• UDI-Device Identifier: 07290016633368
• UDI-Public: 07290016633368
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Consumer
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Patient Monitoring,Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: AG606972A
• Device Catalogue Number: AG606972A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• 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: Required Intervention
• Patient Sex: Male
• Patient Race: White