MAUDE Adverse Event Report: INSIGHTEC LTD. MRGFUS EXABLATE; HIFU

Model Number 2100

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

Patient Problems Inflammation (1932); Bowel Perforation (2668)

Event Date 05/25/2014

Event Type  Injury  

Event Description

In compliance with regulatory requirements such as those in europe, insightec initiated a post marketing surveillance questionnaire to capture customers feedback.One of our customers, dr.(b)(6), cited in their feedback that one of this patients reported a bowel perforation.They also added that their patient suffered with chronic inflammatory disease of the bowel.Patient was treated for their uterine fibroids with the exablate device.For legal reason, we could not get any additional data from the site.However, we have reviewed last year service calls, device maintenance files and actions and found no issues that could suggest device has not been working according to its original specifications and or that device experienced deterioration.Hence, at this time, we are unable to make a full review of the event.

Manufacturer Narrative

For legal reasons, the customer was not able to provide additional detail, when requested by insightec.Due to the lack of additional information from the customer, insightec cannot conclude whether or not the device could have caused or contributed to this injury.In an abundance of caution, the company is submitting this mdr report based solely on the initial limited information provided to the company.It should be noted that the review of the device history did not show any malfunction nor deviation from the device normal operating specifications.

• Brand Name: MRGFUS EXABLATE
• Type of Device: HIFU
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nahum st.; tirat carmel 3912 0; IS 39120
• Manufacturer Contact: ori lubin, manager ; 5 nahum st.; po box 2039; tirat carmel 31229-0 ; IS 312290 ; 54488199
• MDR Report Key: 3876312
• MDR Text Key: 4567710
• Report Number: 9615058-2014-00003
• Device Sequence Number: 1
• Product Code: NRZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2011
• Initial Date FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention