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

Model Number 2100

Device Problem No Apparent Adverse Event (3189)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

Device has been evaluated and determined it works per its specifications and labeled indications.Treatment resulting in injury was in accordance with approved indications and the reported event is a known inherent risk of the procedure.Insightec internal reference (b)(4).

Event Description

During the uterine fibroid treatment, the exablate system detected heating between the patient's right abdominal wall and the gel pad coupling in sonications 51, 57, 61, 69 and 75.The physician stopped the treatment at sonication 75 and re-positioned the patient to finalize the treatment.The overheating on the patient skin reportedly resulted with a 2nd degree skin burn.

• Brand Name: EXABLATE 2100
• Type of Device: MR GUIDED FOCUSED ULTRASOUND
• Manufacturer (Section D): INSIGHTEC, LTD.; 5 nachum heth street; p.o. box 2039; tirat carmel, israel 31290 ; IS 31290
• Manufacturer (Section G): INSIGHTEC, LTD; 5 nachum heth street; p.o. box 2039; tirat carmel, israel 39120 ; IS 39120
• Manufacturer Contact: idan cohen ; 5 nachum heth street; p.o. box 2039; tirat carmel, israel 39120 ; IS 39120
• MDR Report Key: 6897487
• MDR Text Key: 87508946
• Report Number: 9615058-2017-00003
• Device Sequence Number: 1
• Product Code: NRZ
• UDI-Device Identifier: 07290015461016
• UDI-Public: 07290015461016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2017

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: 2100
• Device Catalogue Number: 16111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/14/2017
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other