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 Problem Ambulation Difficulties (2544)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

No system malfunction.Treatment parameters were in line with the typical range.The system performance was found to be according to spec and as expected.No new risk has been recognized.If new details are received in the investigation for this incident, this report will be updated.

Event Description

Patient was treated for essential tremor with focused ultrasound on the left side to treat a right hand tremor.Gait disturbance was observed after the treatment.

Manufacturer Narrative

No system malfunction.Treatment parameters were in line with the typical range.No new risk has been recognized.

Event Description

Patient was treated for essential tremor with focused ultrasound on the left side to treat a right hand tremor.Gait disturbance was observed after the treatment.

• 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: may zimmerman ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 18757989
• MDR Text Key: 335997952
• Report Number: 9615058-2024-00004
• Device Sequence Number: 1
• Product Code: POH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: SYS942000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability