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	Abdominal Pain (1685); Burn(s) (1757); Inflammation (1932); Ascites (2596); Intermenstrual Bleeding (2665); Decreased Appetite (4569)
Date of Event	07/26/2025
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 on august 13th, 2025 that the patient underwent a novasure procedure on (b)(6) 2025, patient was later hospitalized with abdominal pain due to suspected thermal injury.No other information available.
Additional Manufacturer Narrative
Additional information received on (b)(6) 2025, physician reported that the patient is 48 years old female, with atrial fibrillation and on anticoagulation therapy, which presented with vaginal bleeding requiring emergent intervention.Patient received a hysteroscopy, myomectomy and endometrial ablation on (b)(6) 2025.On day 10 post op, patient reported pain and decreased appetite.On day 12 inflammation and decreased appetite and bloating.Patient was admitted to the hospital for further testing and white blood cell count was normal and ct scan showed no free air or fluid but inflammation of fallopian tube.Diffuse tenderness was observed.Patient was started on antibiotics and no white blood cell increase nor infection signs.Patient received 2 more ct scan with oral contrast and intravenous contrast and no free air was observed but inflammation and ascites, a small bowel obstruction was observed.At this point no injury has been reported but patient remains distended and tender.No other information available.

• 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: 22927522
• Report Number: 1222780-2025-00465
• Device Sequence Number: 9162343
• Product Code: MNB
• UDI-Device Identifier: 15420045501126
• UDI-Public: 15420045501126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/04/2025

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: 2013
• Device Catalogue Number: NS2013KITUS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown