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 No Code Available (3191)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures of the system.The system performance was found to be to spec and as expected.Treatment parameters were in line with typical range.No new risk had been recognized.

Event Description

After brain treatment of essential tremor the treated arm and the same side leg appear unbalanced and unsteady during the neurological tests.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC; nachum heth 5; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC; nachum heth 5; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: meital trank ; 5 nachum heth; tirat carmel,, 39120 ; IS 39120
• MDR Report Key: 8815717
• MDR Text Key: 151853484
• Report Number: 9615058-2019-00011
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: SYS940351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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