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 Codes	Tissue Damage (2104); Uterine Perforation (2121); Burn, Thermal (2530)
Date of Event	02/28/2020
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 the procedure, the physician attempted to pass cavity integrity assessment twice.The physician then utilized vaseline and gauze in an attempt to seal the cervix twice but the device would not pass cavity integrity assesment.The device was removed from the patient and reseated, it then passed assessment and the ablation was completed.After ablation was completed, a laparoscopy was performed to complete a planned salpingectomy.On laparoscopy, two areas of blanching as well as a uterine perforation were found.General surgeon noted a burn to the patient colon.Reportedly, the area of concern was removed and the rectal serosa was oversewn.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: 9861047
• Report Number: 1222780-2020-00060
• Device Sequence Number: 2663812
• Product Code: MNB
• UDI-Device Identifier: 35420045501137
• UDI-Public: (01)35420045501137(10)19L21RT
• 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): 02/28/2020

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: 12/21/2020
• Device Model Number: NS2007
• Device Catalogue Number: NS2007
• Device Lot Number: 19L2RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/20/2020
• 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; Required Intervention