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

Model Number 4000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

The cause of this reported incident is still under investigation.

Event Description

Patient experienced burn blisters on their head following essential tremor treatment.

Manufacturer Narrative

No failures of the system were reported.The treatment process was as expected.All treatment parameters were within specifications.The location of the reported blister was outside the treatment area and only one side of the head.Therefore this skin injury does not appear to be related to the transmitted energy or the membrane material.The skin injury may be related to pressure on the patient's forehead but this cannot be verified.No root cause was identified.Since the blisters resolved, this is a transient event.

Event Description

Burn blisters were positioned on the side of the patient's head in the area where the membrane contacts the patient.The patient had no symptoms during the treatment.The blisters have completely resolved without any additional symptoms.

• 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: 18189863
• MDR Text Key: 328739271
• Report Number: 9615058-2023-00032
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/06/2024

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: SYS940100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 03/06/2024
• 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): Other; Disability