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

Model Number	V5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a novasure procedure on (b)(6) 2025, the cavity integrity assessment test failed, and it was noted the cervical collar was dislodged from the handpiece inside the patient.The procedure was aborted and a resectoscope was used to retrieve the collar from the patient.A hysteroscope was used to check the cavity after removal and no injury was reported.The patient was sent home without any complications.
Additional Manufacturer Narrative
The device was returned for investigation: visual inspection was conducted and the cervical seal was detached from the pusher and was sent in the packaging with the device.Functional testing was not conducted, the issue was confirmed in the visual inspection.Hence, the complaint can be confirmed.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.We are currently unable to establish a relationship between the device and the issue reported.

• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102 ; CR 20102
• MDR Report Key: 21741066
• Report Number: 1222780-2025-00154
• Device Sequence Number: 20991475
• Product Code: MNB
• UDI-Device Identifier: 15420045514294
• UDI-Public: (01)15420045514294(17)260919(10)24H30RQ
• 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): 04/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2026
• Device Model Number: V5
• Device Catalogue Number: NSV5US-001
• Device Lot Number: 24H30RQ-0854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown