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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSIGHTEC EXABLATE 4000; MR-GUIDED FOCUSED ULTRASOUND SYSTEM

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INSIGHTEC EXABLATE 4000; MR-GUIDED FOCUSED ULTRASOUND SYSTEM Back to Search Results
Model Number 4000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Shaking/Tremors (2515)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
The retrospective analysis has not indicated any technical failures of the system.Treatment parameters were in the typical range observed.The system was found to be in spec and as expected.No new risk recognized.No new recommendations or corrective actions.
 
Event Description
After brain treatment of essential tremor, at 24 hours post-treatment follow up, patient presented slight left facial droop.No additional or longer term follow up data is available.
 
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Brand Name
EXABLATE 4000
Type of Device
MR-GUIDED FOCUSED ULTRASOUND SYSTEM
Manufacturer (Section D)
INSIGHTEC
5 nachum heth street
39120
IS  39120
Manufacturer (Section G)
INSIGHTEC
5 nachum heth
tirat carmel,
IS  
Manufacturer Contact
meital trank
5 nachum heth
tirat carmel, 39120
IS   39120
MDR Report Key9435055
MDR Text Key173325997
Report Number9615058-2019-00018
Device Sequence Number1
Product Code POH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/08/2019
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 Number4000
Device Catalogue NumberSYS004000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2019
Initial Date FDA Received12/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Disability;
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