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

Model Number	NS2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Type of Reportable Event	Serious Injury
Additional 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.According to the instructions for use (ifu).Warnings: · use caution not to perforate the uterine wall when sounding, dilating, or inserting the disposable device.· if the disposable device is difficult to insert into the cervical canal, use clinical judgment to determine whether or not further dilation is required.· the novasure system performs a cavity integrity assessment (cia) test to evaluate the integrity of the uterine cavity, and sounds an alarm warning of a possible perforation prior to treatment.Reference internal complaint (b)(4).
Event or Problem Description
Note: this report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report# 1222780-2017-00260.It was reported the physician attempted a novasure endometrial ablation on (b)(6) 2017, and received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices.The doctor performed a laparoscopy and visualized a perforation.No intervention was required and the patient was discharged home.A hysteroscopy, dilatation and curettage (d&c), and sounding with a metal sound (not hologic devices) were performed prior to the attempted ablation.It is not known when this perforation occurred or what instrument may have been the cause.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Common Device Name: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 6980722
• Report Number: 1222780-2017-00258
• Device Sequence Number: 156178
• Product Code: MNB
• UDI-Device Identifier: 45420045501134
• UDI-Public: (01)45420045501134(10)17F28RH
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2017

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
• Operator of Device: Physician
• Device Expiration Date: 07/28/2018
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: 17F28RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADIO FREQUENCY CONTROLLER: SERIAL# UNKNOWN
• Outcome Attributed to Adverse Event: Other