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

Model Number 2100

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

Patient Problem Burn(s) (1757)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

This complaint includes known side effects for uf treatment.No new risks were identified.No device malfunction was detected.Treatment parameters were in line with the typical range.

Event Description

Skin burn and prolonged hospitalization for observation, following uterine fibroids (uf) treatment.

• Brand Name: EXABLATE 2100
• 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: lena taratetsky ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 16416294
• MDR Text Key: 309948344
• Report Number: 9615058-2023-00004
• Device Sequence Number: 1
• Product Code: NRZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2023

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: 2100
• Device Catalogue Number: SYS910005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/22/2023
• 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): Hospitalization; Disability
• Patient Sex: Female