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

Model Number 2000

Device Problem Insufficient Information (3190)

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

Event Date 07/18/2014

Event Type  Injury  

Event Description

Pt underwent an uneventful mrgfus procedure on (b)(6) 2014, but experienced severe pain immediately after the procedure.She was readmitted at (b)(6) on the (b)(6) 2014 with pain and had an axr/cxr demonstrating fecal loading and no frank obstruction/perforation and a pelvic ultra sound demonstrating a moderate amount of free fluid/reactive but nil other abnormality.The pt was afebrile, normotensive, without tachycardia and had a soft abdomen with pain predominantly over her uterus.Crp was 5, initial wcc 13.5 which 12/24 later was 5.5.She was given aperients for constipation and emptied her bowels.She was discharged home on the (b)(6) feeling better.The pt subsequently presented 36 hours later with an acute abdomen to (b)(6), had evidence of a small bowel perforation at laparotomy and underwent a small bowel resection with abdominal cavity washout.As of (b)(6) the pt is recovering well.

Manufacturer Narrative

Device has been diagnosed to work according to it's specs.Reason of adverse event is user error.Insightec training material already explains and address improvement of procedure.Site is going to be trained following this event.

• Brand Name: MRGFUS EXABLATE
• Type of Device: HIFU
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nahum het; tirat carmel 3912 0; IS 39120
• Manufacturer Contact: ori lubin, mgr ; 5 nahum st.; po box 2039; tirat carmel 31290 ; IS 31290 ; 544881399
• MDR Report Key: 4028120
• MDR Text Key: 4799152
• Report Number: 9615058-2014-00005
• 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: 08/12/2014

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: 2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 08/13/2014
• 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: 34 YR