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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Shaking/Tremors (2515)
Event Date 04/11/2022
Event Type  Injury  
Manufacturer Narrative
This complaint included known side effects.Tremor on the right hand seems to be unrelated and most likely due to progressional disease.No new risks were identified.
 
Event Description
Three months after treatment, patient reported a complaint through the company website.One month after the treatment, side effects such as tremor, numbness and gait issues began to show on the left side of the body where the treatment was performed.In addition, tremor also appeared on the right hand.
 
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Brand Name
EXABLATE 4000
Type of Device
MR GUIDED FOCUSED ULTRASOUND SYSTEM
Manufacturer (Section D)
INSIGHTEC LTD.
5 nahum heth street
tirat carmel, 39120
IS  39120
Manufacturer (Section G)
INSIGHTEC LTD.
5 nachum heth
tirat carmel, 39120
IS   39120
Manufacturer Contact
may zimmerman
5 nachum heth
tirat carmel, 39120
IS   39120
MDR Report Key15198368
MDR Text Key297673476
Report Number9615085-2022-00017
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/10/2022
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 Model Number4000
Device Catalogue NumberSYS942202
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/11/2022
Initial Date FDA Received08/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
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