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	Foreign Body In Patient (2687)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that during a novasure procedure on (b)(6) 2025, the physician reported that after successfully completing the ablation, the physician reported having difficulty removing the array and that it seemed stuck.The physician was able to successfully retract the array and remove the device from the patient.They checked the array after removing it from the patient and observed a hole in the array.The sheath of the device appeared slightly crumpled.A hysteroscopy was performed and some material was found left in the uterus.The physician removed 2 pieces of material from the uterus and noted that there seemed to be small pieces/flakes left behind that could not be removed.A myosure procedure was performed prior to the novasure procedure in the same visit.No anatomical or structural abnormalities were observed.No further intervention has been performed.
Additional Manufacturer Narrative
Device was returned for investigation: visual inspection was conducted, and the tip of the sheath is melted and a hole was found in the array (the hole is in both poles facing the handle.Additionally, the external sheath tip is malformed.Functional testing was not conducted because the issue could be confirmed during the visual inspection.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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 22510183
• Report Number: 1222780-2025-00384
• Device Sequence Number: 12948001
• Product Code: MNB
• UDI-Device Identifier: 15420045514294
• UDI-Public: (01)15420045514294(17)261222(10)24M02RC
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: V5
• Device Catalogue Number: NSV5KITUS-001
• Device Lot Number: 24M02RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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