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 Balance Problems (4401)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

This complaint included known side effects.No malfunction was described.No new risk has been recognized.

Event Description

Patient reported balance issues after essential tremor treatment.

• 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: 13495278
• MDR Text Key: 285327701
• Report Number: 9615058-2022-00011
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461021
• UDI-Public: 01072900154610211200514214082
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/09/2022

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: SYS940000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Male