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	Uterine Perforation (2121)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that prior to starting the ablation, the physician performed a hysteroscopy and the uterus was intact.The physician then attempted to perform the ablation but the device would not pass cavity integrity assessment, the physician suspected she had perforated.The procedure was then aborted.No additional details available.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Common Device Name: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough, ma
• MDR Report Key: 9949458
• Report Number: 1222780-2020-00072
• Device Sequence Number: 11587299
• Product Code: MNB
• UDI-Device Identifier: 45420045501134
• UDI-Public: (01)45420045501134(10)19M19RP
• Combination Product (Y/N): N
• 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): 03/16/2020

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: 01/19/2021
• Device Model Number: NS2007
• Device Catalogue Number: NS2007
• Device Lot Number: 19M19RP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/10/2020
• 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