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

Model Number 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 03/14/2023

Event Type  Injury  

Manufacturer Narrative

Known risk of the device.No new risk has been recognized.

Event Description

Skin burns at stereotactic frame pin sites following essential tremor treatment.

Manufacturer Narrative

Known risk of the device.No new risk has been recognized.No device malfunction.Skin burns healed completely and therefore event was transient.Since burns only appeared two days after treatment, and were only present at two out of four contact points with the skin, it is possible that the adverse event is not device related.

Event Description

Skin burns at stereotactic frame pin sites on the forhead were seen two days after essential tremor treatment.

• 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 Key: 16822056
• MDR Text Key: 314074812
• Report Number: 9615058-2023-00013
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461021
• UDI-Public: 010729001546102112109022140101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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 Number: 4000
• Device Catalogue Number: SYS940350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 06/15/2023
• 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 Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Male