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

Model Number	2013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bowel Burn (1756); Pain (1994)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a novasure procedure on (b)(6) 2025, a check was performed with a hysteroscopy and everything looked normal.The cavity integrity assessment test passed on the first try.The ablation lasted around a minute.Patient recovered well in the post operation and was discharged and sent home the same day.Later that night, it was reported that the patient was in a lot of pain and was admitted to the hospital.The patient was discharged from the hospital but on (b)(6) 2025, the patient was back at the hospital where it was noticed that she had a bruise on the bowel but no signed of perforation was noted.On (b)(6) 2025, surgery was done and a small piece of bowel was removed.Patient is now recovering well at the hospital on a special diet and taking antibiotics.No other information is available.
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.
Additional Manufacturer Narrative
Additional information received from the physician: the procedure performed was uneventful.Procedure was performed as a routine and was completed without any difficulty.It was an uncomplicated procedure at that time.Patient was discharged home in stable condition.The next day the patient was admitted to the hospital with abdominal pain.She stayed for 2 days at the hospital and was discharged home.She was later admitted a day after and underwent bowel resection.The surgeon reported that the uterus did not have a perforation but a bruise was present at the fundus of the uterus.Bowel injury was suspected at the time.The mechanism of the injury was unknown by the physician.

• 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: 23877952
• Report Number: 1222780-2025-00648
• Device Sequence Number: 4706302
• Product Code: MNB
• UDI-Device Identifier: 15420045501119
• UDI-Public: (01)15420045501119(17)270716(10)25F26RT
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 2013
• Device Catalogue Number: NS2013KITUS
• Device Lot Number: 25F26RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RFC2010-115
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown