MAUDE Adverse Event Report: INSIGHTEC LTD. EXABLATE 2100V1; MR-GUIDED FOCUSED ULTRASOUND SYSTEM

Model Number 2100V1

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

Patient Problem Burn, Thermal (2530)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

No new risks related to device performance were identified.

Event Description

This report pertains to one of three events that were received from the same site in the same timeframe.After uterine fibroid treatment the patient presented with severe skin burn.

Manufacturer Narrative

The clinical retrospective analysis does not represent new risks.The skin heating was identifiable in the real time thermal images.This was observed by the clinical team and a decision was made to continue despite the possible risk.After follow up visit, the site reported that the skin burn was healed without any complications.

Event Description

After uterine fibroid treatment the treating physician reported severe skin burns.In 2 weeks follow up, site reported that the wounds are healing and no signs for superinfection.In 2 months follow up, site reported that all skin burns healed without complications.

• Brand Name: EXABLATE 2100V1
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nachum heth st.; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 9479027
• MDR Text Key: 173326938
• Report Number: 9615058-2019-00025
• Device Sequence Number: 1
• Product Code: NRZ
• Combination Product (y/n): N
• PMA/PMN Number: P040003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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
• Device Operator: Health Professional
• Device Model Number: 2100V1
• Device Catalogue Number: SYS910350
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability