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 Weakness (2145); Dysphasia (2195)

Event Date 03/17/2020

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 according to spec and as expected.No new risk was recognized.

Event Description

Patient underwent brain treatment for essential tremor.No side effects were reported by the site during or immediately after the treatment.Three weeks following the treatment, the physician reported that the patient developed speech difficulties and hemiparesis after the procedure and is in a nursing home for physical therapy.The physician updated that by the time of the follow up, patient's speech has slowly gotten better to almost normal during the time passed and is getting stronger physically but is still too weak to walk on his own.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: meital trank ; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 10032513
• MDR Text Key: 191833094
• Report Number: 9615058-2020-00010
• 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: 05/07/2020

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: No Information
• Device Model Number: 4000
• Device Catalogue Number: SYS940350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• 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