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

Model Number 2100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Peritonitis (2252); Bowel Perforation (2668)

Event Date 12/15/2014

Event Type  Injury  

Event Description

Treatment flow was without exceptional events, although the pt stopped the treatment several times due to lower abdominal cramps.At the end of the treatment the pt was dismissed with mild cramps and bloating symptom.During the following two days (weekend) the patient had abdominal pain and on monday (3 days after the treatment) she was operated in another hospital for peritonitis.Laparotomy revealed a small bowel transmural perforation; with local signs of peritonitis.The area with the perforation was resected with primary anastomosis, and the abdominal cavity was irrigated.Post-surgery recovery of the pt was without any complications.

Manufacturer Narrative

Device was reviewed to operating within its specifications.Reason of adverse event is user error.Insightec training material already explains and address such situations.Insightec findings were presented and discussed with the site.

• Brand Name: MRGFUS EXABLATE
• Type of Device: HIFU
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nahum st.; tirat carmel 3912 001; IS 3912001
• Manufacturer Contact: ori lubin, manager ; 5 nahum heth street; p.o. box 2039; tirat carmel 31290 ; IS 31290 ; 544881399
• MDR Report Key: 4447821
• MDR Text Key: 19496915
• Report Number: 9615058-2015-00001
• Device Sequence Number: 1
• Product Code: NRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/15/2015

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: 01/11/2015
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 40 YR