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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSIGHTEC LTD EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM
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INSIGHTEC LTD EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM Back to Search Results
Model Number 4000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Muscle Weakness/Atrophy (1967); Balance Problems (4401)
Date of Event 08/18/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The retrospective analysis has not indicated any technical failures or erroneous operation of the system.Treatment parameters were in line with the typical range.The system performance was found to be to spec and as expected.No new risk has been recognized.
 
Event or Problem Description
24 hours post treatment for essential tremor, patient reported leg weakness and imbalance, which was still existing 1 week after the treatment.
 
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Brand Name
EXABLATE 4000
Common Device Name
MR GUIDED FOCUSED ULTRASOUND SYSTEM
Manufacturer (Section D)
INSIGHTEC LTD
5 nachum heth street
tirat carmel, 39120
IS  39120
MDR Report Key10539076
Report Number9615058-2020-00018
Device Sequence Number3410150
Product Code POH
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P150038
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/16/2020
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
Operator of Device Health Professional
Device Model Number4000
Device Catalogue NumberSYS940000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/19/2020
Initial Report FDA Received Date09/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
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