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

Model Number 4000 TYPE 1.0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Exablate neuro silicone membrane failed during treatment, pumped water into energized mri scanner.

Event Description

Exablate neuro silicone membrane failed during treatment, pumped water into energized mri scanner.No harm to the patient or providers occurred.The procedure was stopped.The vendor was present at the time of the incident.

• Brand Name: EXABLATE NEURO
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 4851 lbj frwy, #400; dallas TX 75244
• MDR Report Key: 13365994
• MDR Text Key: 284535759
• Report Number: 13365994
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/12/2022,12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4000 TYPE 1.0
• Device Catalogue Number: EXABLATE 4000 TYPE 1.0
• Device Lot Number: ASC002258-AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Female