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

Model Number	NS2013US
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Error message mid procedure.Device would not move past analyzing step and could not troubleshoot or get to function.Opened and used a new unit to complete the procedure.

• Brand Name: NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 23423788
• Report Number: 23423788
• Device Sequence Number: 15902367
• Product Code: MNB
• UDI-Device Identifier: 15420045501119
• UDI-Public: (01)15420045501119
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025
• Report Date (Section F): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: NS2013US
• Device Catalogue Number: NS2013US
• Device Lot Number: 24G30RG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/17/2025