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 Dysphagia/ Odynophagia (1815)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

This complaint included known side effects.No malfunction was described.No new risk has been recognized.

Event Description

Swallowing difficulty (dysphagia) persist after essential tremor treatment.

Manufacturer Narrative

This complaint included known side effects.No malfunction was described.No new risk has been recognized.

Event Description

Swallowing difficulty (dysphagia) persist after essential tremor treatment.This follow up report is following new information that was recieved from the treating physician, that believes the reported side effects are not permanent and will be resolved.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 12553717
• MDR Text Key: 274000048
• Report Number: 9615058-2021-00026
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

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 Number: 4000
• Device Catalogue Number: SYS940350
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability