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

Model Number	NS2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/26/2020
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
On september 09, 2020 hologic was notified of an event involving the novasure device which occurred on (b)(6) 2020.It was reported that the physician was unable to complete the novasure procedure due to the device failing to open completely.The procedure was aborted and a second device was not opened to attempt to complete the procedure.The patient was sent to the er due for heavy bleeding and ct.The patient was later sent home from er stable with improved conditions.No additional details available.
Additional Manufacturer Narrative
The returned device was received and tested.The device successfully passed cavity integrity assessment (cia), and ablation testing.The product performed as intended during laboratory testing.No visual imperfections were noted with the device electrode array.The reported complaint and adverse event cannot be confirmed.This observation will be monitored and trended.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA DEVICE
• Common Device Name: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 10602462
• Report Number: 1222780-2020-00129
• Device Sequence Number: 14260881
• Product Code: MNB
• UDI-Device Identifier: 15420045501140
• UDI-Public: (01)15420045501140(10)19H19RK(17)210319
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 03/19/2021
• Device Model Number: NS2007
• Device Catalogue Number: NS2007
• Device Lot Number: 19H19RK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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, SN UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Other