MAUDE Adverse Event Report: INMODE LTD. VASCULAZE; GEX

Model Number	AG605988A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
Full thickness burn on posterior leg following treatment with vasculaze.
Additional Manufacturer Narrative
12-nov-2025: follow up report is submitted with investigation conclusions.The device was inspected and no technical issues were revealed.The root cause was attributed to several user errors: firing over an existing bruise, which absorbed all the light energy and caused a burn.This was most likely combined with additional technique-related errors, such as firing without full contact or insufficient amount of coupling gel, making the energy accumulate at the surface.The clinic received a retraining and the patient healed.
Event or Problem Description
Full thickness burn on posterior leg following treatment with vasculaze.

• Brand Name: VASCULAZE
• Common Device Name: GEX
• 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: 23179583
• Report Number: 3010511300-2025-00916
• Device Sequence Number: 9146130
• Product Code: GEX
• UDI-Device Identifier: 07290019863168
• UDI-Public: 07290019863168
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K251632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Patient Monitoring,Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: Other
• Device Model Number: AG605988A
• Device Catalogue Number: AG613079A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• 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: 37 YR
• Patient Sex: Female
• Patient Race: White