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

Model Number 4000

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

Patient Problem Tingling (2171)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures or erroneous operation of the system.Treatment parameters were in line with typical range.The system performance was found to be to spec and as expected.No new risk recognized and current mitigations to the above risk were in effect.

Event Description

In a brain treatment of essential tremor, the patient reported mild tingling feeling along the pads of the fingertips on the treated (right) side, as well as mild tingling in the lower right lip.Sensation lessened slightly throughout treatment but was still present following the final sonication.

• Brand Name: EXABLATE 4000
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC; 5 nachum heth street; tirat carmel 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC; 5 nachum heth; tirat carmel, israel ; IS
• Manufacturer Contact: meital trank ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 8730697
• MDR Text Key: 149072286
• Report Number: 9615058-2019-00008
• 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: Physician
• Type of Report: Initial
• Report Date: 06/25/2019

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: SYS004000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability