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

Model Number 2000

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Peritonitis (2252)

Event Date 09/17/2014

Event Type  Injury  

Event Description

A (b)(6) year old woman with adenomyosis and menometrorrhagia was "commercially" treated on (b)(6) with no remarkable events.In hr pas the patient underwent myomectomy by laparotomy and several ivf attempts.Three days post-treatment ((b)(6) 2014) the patient complaint of abdominal pain and was referred to the emergency room.She arrived to the er on (b)(6) 2014.Following deterioration of her condition, she was taken to emergency for a laparotomy.It was reported indirectly to insightec that at laparotomy feces was found in the abdominal cavity but no apparent perforation of perforation site was detected.The patient dies on (b)(6) 2014.On (b)(6) pm was performed.At this time, the pm results are not available, per hospital management decision.No other information is available at this time as well.

Manufacturer Narrative

Device has been diagnosed and found with no malfunctions.Site did not allow treatment review yet.

• 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 st.; po box 2039; tirat carmel 31290 ; IS 31290 ; 54488199
• MDR Report Key: 4146933
• MDR Text Key: 4766747
• Report Number: 9615058-2014-00006
• 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: 09/17/2014

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: 05/16/2011
• Initial Date FDA Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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): Death
• Patient Age: 41 YR