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

Model Number	V5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bowel Burn (1756); Fever (1858); Uterine Perforation (2121)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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 during a novasure procedure on (b)(6) 2026, that the device was initially seated and the cavity integrity test passed.The ablation began and the ablation time was 1 minute and 8 seconds when the vacuum alert displayed and the ablation was stopped.It was then verified that the tubing was hanging below the patient's leg.No leak was noted at the cervix, no fluid was overflowing the tubing to the desiccant, and the vacuum valve was actuated.The vacuum alert continued and that's when the physician chose to try another device.After seating the array on the second device, the cavity assessment test failed and a hysteroscopy was performed.A perforation at the fundus was noted and the physician then performed a laparoscopy to repair and suture the perforation, and the surgery was successful.No additional injury noted to the surrounding structures.The patient is waking up from surgery.No further surgery or medication was administered to the patient.No other information is available.
Additional Manufacturer Narrative
Additional information received: the patient was experiencing abdominal pain and had a fever, so the patient went to emergency (er).Upon examining the patient, it was found that the patient had a bowel burn.A bowel resection was then performed.The patient is still in the hospital and recovering.

• 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: 24429797
• Report Number: 1222780-2026-00081
• Device Sequence Number: 10303739
• Product Code: MNB
• UDI-Device Identifier: 15420045514300
• UDI-Public: 15420045514300
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/03/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization; Required Intervention
• Patient Sex: Unknown