MAUDE Adverse Event Report: INMODE LTD. VASCULAZE; GEX

Model Number	AG605988A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Necrosis (1971); Full thickness (Third Degree) Burn (2696)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Full thickness burns with necrosis on posterior leg and thigh following treatment with vasculaze.
Additional Manufacturer Narrative
No technical inspection of the device was performed, as the customer confirmed the device works with no issues.The customer disclosed that the treatment was done by a previous employee that is no longer employed at their clinic.Investigation attributed the root cause to an incorrcet technique: it seems the operator fired without full contact on the same spot several times, leading to full thickness burns.Patient's compromised circulatory efficiency most probably further contributed to a delayed healing and the observed necrosis.Nevertheless, the lesions are dry, not infected and gradual re-epithelialization is seen.A retraining has been scheduled for this clinic.
Additional Manufacturer Narrative
No technical inspection of the device was performed, as the customer confirmed the device works with no issues.The customer disclosed that the treatment was done by a previous employee that is no longer employed at their clinic.Investigation attributed the root cause to an incorrect technique: it seems the operator fired without full contact on the same spot several times, leading to full thickness burns.Patient's compromised circulatory efficiency most probably further contributed to a delayed healing and the observed necrosis.Nevertheless, the lesions are dry, not infected and gradual re-epithelialization is seen.A retraining has been scheduled for this clinic.On 24-nov-2025: follow-up report is submitted with additional information.B7 - typo was corrected.Despite several attempts to schedule a retraining for the clinic, they became non responsive.For the same reason, inmode could not obtain any updated information regarding patient's healing.
Event or Problem Description
Full thickness burns with necrosis on posterior leg and thigh 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: 22962245
• Report Number: 3010511300-2025-00892
• Device Sequence Number: 18608828
• Product Code: GEX
• UDI-Device Identifier: 07290019863168
• UDI-Public: 07290019863168
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring,Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: Health Professional
• Device Model Number: AG605988A
• Device Catalogue Number: AG613079A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 62 YR
• Patient Sex: Female
• Patient Race: White