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

Model Number	NS2013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a novasure endometrial ablation procedure on (b)(6) 2020 the physician called to report an issue with the device failing the cavity integrity assessment (cia) test.The physician attempted to perform troubleshooting steps to ensure a complete cervical seal including vaseline gauze and a second tenaculum to the cervix to obtain a better seal.The cia was attempted again and the test had failed.The physician then performed a hysteroscopy before opening a second disposable device and noted that a uterine perforation was observed at the fundus.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
• Common Device Name: ENDOMETRIAL THERMAL ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 10569813
• Report Number: 1222780-2020-00122
• Device Sequence Number: 2670596
• Product Code: MNB
• UDI-Device Identifier: 15420045501133
• UDI-Public: (01)15420045501133(10)20B18RD(17)210318
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 03/18/2021
• Device Model Number: NS2013
• Device Catalogue Number: NS2013
• Device Lot Number: 20B18RD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1