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 Partial thickness (Second Degree) Burn (2694)

Event Date 06/29/2022

Event Type  Injury  

Event Description

Patient had abdominal 2nd degree skin burn, with blisters in the burn area, with dimensions of approximately 5 x 4 cm, immediately after uf treatment.Patient received standard disinfection and antibacterial drugs treatment.However, patient decided to stop medications intake and undergo surgery.Patient underwent surgery on (b)(6) 2022, at another hospital, and is feeling well, as of (b)(6) 2022.

Manufacturer Narrative

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

• 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: may zimmerman ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 15379069
• MDR Text Key: 299475202
• Report Number: 9615085-2022-00021
• Device Sequence Number: 1
• Product Code: NRZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/07/2022

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 Number: 2100
• Device Catalogue Number: SYS910353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/08/2022
• 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 Number: 1
• Patient Outcome(s): Disability; Required Intervention