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

Model Number	NS2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated on 06/07/2018.The device passed the cia test and ablation testing.No defects were observed on the returned unit.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 the physician performed a novasure endometrial ablation on (b)(6) 2018 and received an unsuccessful cavity integrity assessment (cia) test.The physician then performed a hysteroscopy and noted a perforation.No intervention was required.The procedure was aborted and the patient was discharged home.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Common Device Name: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• Manufacturer Contact: david ramsay ; 250 campus drive; marlborough, ma ; 2638713
• MDR Report Key: 7630116
• Report Number: 1222780-2018-00111
• Device Sequence Number: 3611005
• Product Code: MNB
• UDI-Device Identifier: 15420045501133
• UDI-Public: (01)15420045501133(10)17K18R(17)181118
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: 11/18/2018
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: 17K18R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 06/22/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADIO FREQUENCY CONTROLLER, SN UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female