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

Model Number	NS2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a novasure endometrial ablation on (b)(6) 2018 the device did not ablate completely.A representative followed up with the physician on (b)(6) 2018 and additional information was obtained.The physician noted that the cavity integrity assessment (cia) passed with no issue and the ablation was completed.When the physician tried to remove the device it seemed to retract into the sheath, but she could not remove it from the patient.Once it was removed the plastic sheath looked melted.The cavity was viewed and did not look ablated like it typically is.The physician also noted that the cervix had some burn and there was stenosis.She tried going back in with a second device to ablate what was missed, but could not get the device to advance through the cervix and aborted the attempt.The patient was discharged home the same day.

• 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: 8249071
• Report Number: 1222780-2019-00010
• Device Sequence Number: 1593624
• Product Code: MNB
• UDI-Device Identifier: 35420045501137
• UDI-Public: 35420045501137
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/17/2018

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: Health Professional
• Device Expiration Date: 09/16/2019
• Device Model Number: NS2007
• Device Catalogue Number: NS2007
• Device Lot Number: 18H16R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other