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

Model Number	V5
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a novasure procedure on (b)(6) 2025, that there was a valve problem and an error message appeared several times without being able to complete the intervention.A second device was used to complete the procedure.Upon investigation on (b)(6) 2026.A hole in the array was reported.
Additional Manufacturer Narrative
Device was returned: visual inspection was conducted and the array was stuck in the closed position and had blood.During deployment of the array, dried tissue and blood made it difficult to deploy.After a couple of tries, it was possible to deploy but a hole was identified in the proximal end of the array.Suction test with syringe was passed.Functional testing was conducted and the device passed the test in the console without any issues or messages on the screen.Therefore, the issue reported by the customer was not replicated, but a different failure mode of the hole in the array was identified.This observation will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• Brand Name: NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: simran keswani ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 24571487
• Report Number: 1222780-2026-00112
• Device Sequence Number: 13120137
• Product Code: MNB
• UDI-Device Identifier: 15420045514300
• UDI-Public: (01)15420045514300(17)261017(10)24J27RB
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: Health Professional
• Device Model Number: V5
• Device Catalogue Number: NSV5KITUS-001
• Device Lot Number: 24J27RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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
• Patient Sex: Unknown