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

Model Number NS2000

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/23/2016

Event Type  malfunction  

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).

Event Description

It was reported a physician performed a novasure endometrial ablation on (b)(6) 2016 and fibers from the electrode array were visualized floating around the uterine cavity.The physician removed them with "graspers" and the procedure was completed.No patient injury.

• 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: 6181639
• MDR Text Key: 62966647
• Report Number: 1222780-2016-00299
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 15420045501140
• UDI-Public: (01)15420045501140(17)180322(10)16H22RA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/22/2018
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: 16H22RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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
• Treatment: RADIO FREQUENCY CONTROLLER - SERIAL NUMBER# UNK