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

Model Number 2100

Device Problem No Apparent Adverse Event (3189)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

Device has been evaluated and determined it works per its specifications and labeled indications.Treatment resulting in alleged injury was off-label use not in accordance with approved indications.(b)(4).Note: initial report submitted to fda in 9615058-2016-00002 on 03-02-2016 but not visible in maude.Follow-up report being submitted for traceability/ documentation purposes only.There is no change from the initial report.

Event Description

Treating physician reported to insightec an event related to off-label use of exablate 2100 (p040003/s016 uterine fibroids indication) on (b)(6) year old male.Per their report, the post-treatment examination of the skin showed a 5cm third degree skin burn with blistering.The center of this burn was white surrounded with a hyperemic area.The patient was prescribed for antibiotics to minimize the risk of infection and is now under the care of plastic surgery and dermatology for wound care.

• Brand Name: EXABLATE MRGFUS
• 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: 6829296
• MDR Text Key: 83936938
• Report Number: 9615058-2016-00002
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2016,08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2100
• Device Catalogue Number: ExAblate 2100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2016
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 53 YR