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

Model Number 4000 TYPE 1.0

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

Exablate neuro silicone membrane failed causing water to be pumped into the mr scanner.

• 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: 13366006
• MDR Text Key: 284535806
• Report Number: 13366006
• 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
• 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
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Male