MAUDE Adverse Event Report: INMODE LTD. VASCULAZE; GEX

Model Number	AG605988A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Ulcer (2274); Full thickness (Third Degree) Burn (2696); Skin Infection (4544)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No technical issues related to the incident were identified upon inspection of the device.The investigation attributed the root cause to user error: the operator treated a patient with contraindication per ifu: venous insufficiency.It seems that initially the burn was caused by firing too many times at the same spot or hitting a large vessel (or a cluster of veins), which absorbed all the energy.It is also possible that the provider fired without full contact.Further, the lesion got ulcerated and infected due to venous insufficiency (ulceration and infection are known complications of venous insufficiency even in cases of small wounds).Per latest update, the patient is healing well.The clinic received a retraining.
Event or Problem Description
Full thickness burn with subsequent ulceration and infection on lower 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: 20289411
• Report Number: 3010511300-2024-00640
• Device Sequence Number: 15475320
• Product Code: GEX
• UDI-Device Identifier: 07290016633290
• UDI-Public: 07290016633290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221571
• 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: Inspection,Other,Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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: AG605988A
• Device Catalogue Number: AG605988A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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: 40 YR
• Patient Sex: Female
• Patient Race: White