MAUDE Adverse Event Report: INSIGHTEC LTD. EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM

Model Number 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Paralysis (1997); Confusion/ Disorientation (2553)

Event Date 02/27/2023

Event Type  Injury  

Event Description

Aphasia and right-sided paralysis.

Manufacturer Narrative

No malfunction was described or detected during the investigation.The patient did not exhibit ablation-related side effects during or immediately after the procedure and the temperatures that were reached were below the ablative range.No new risk has been recognized.No files are attached.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nahum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD.; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: lidar dvir ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 16642365
• MDR Text Key: 312285723
• Report Number: 9615058-2023-00010
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911201203214232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2023

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
• Device Model Number: 4000
• Device Catalogue Number: SYS942200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Sex: Male