MAUDE Adverse Event Report: HOLOGIC, INC NOVASURE IMPEDANCE CONTROLLED EA SYSTEM; UTERINE ABLATION DEVICE

Model Number NS2000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Currently unable to establish a relationship or impact to the reported observation.(b)(4).

Event Description

It was reported a physician performed a novasure endometrial ablation on (b)(6) 2016.Upon removal of the disposable device, "part of the array mesh became embedded in the cavity".The pieces were removed.No further complications were reported and the patient was discharged home.

Manufacturer Narrative

Device history record (dhr) review was conducted for the identified lot number and serial number of the disposable device.No abnormalities were found related to the reported information.This device passed final testing prior to release.(b)(4).

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Type of Device: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5652818
• MDR Text Key: 46398687
• Report Number: 1222780-2016-00121
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010013
• 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,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/11/2017
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: 15J11R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• 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