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

Model Number	2013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067)
Date of Event	11/14/2025
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 that the novasure procedure occurred on (b)(6) 2025, and the patient presented to the hospital the next day on (b)(6) 2025, with sepsis.The physician stated the patient's health is poor and there are many other co-morbidities.The patient received a magnetic resonance imaging (mri) on (b)(6) 2025 and was admitted to the hospital.Bleeding has stopped.Additional information received: the patient had many co-morbidities and was anemic and bleeding.The physician performed uterine artery embolization and tried intra-uterine device with no success.Following the novasure procedure, the patient presented with sepsis.Per a clinical discussion, the bacteria indicated was more common with urinary tract infections and the physician stated that ¨perhaps the novasure was not the source of the infection¨.The bladder was accessed post the novasure procedure.No other information is available.

• Brand Name: NOVASURE SURESOUND
• 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: 23728032
• Report Number: 1222780-2025-00623
• Device Sequence Number: 10258784
• Product Code: MNB
• UDI-Device Identifier: 15420045501126
• UDI-Public: 15420045501126
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 12/05/2025

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: 11/21/2025
• Initial Report FDA Received Date: 12/05/2025
• 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; Other
• Patient Sex: Unknown