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

Model Number	2013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/13/2026
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 the patient underwent a hysteroscopy, myosure and a novasure procedure.After successfully completing the hysteroscopy and myosure, the physician performed novasure ablation.The physician went back into the cavity and noted that the cervix has been ablated and not the endometrial cavity.The physician prescribed the patient with a treatment post operation.The patient is doing well.No other information is available.
Additional Manufacturer Narrative
G1.Manufacturer contact country code : correct one is cr.
Additional Manufacturer Narrative
Additional information received: the patient was a 35-year-old with two prior c sections.The patient experienced discharge, capacious cervix but tenaculum was used.A prior dilation and curettage (d&c) were performed prior to ablation with no fibroids identified.During the novasure procedure, it did not dilate beyond 2.5 cm initially.The measured cavity length was 4 cm.However, dilation was performed to 5 cm to match the cavity length.The device was inserted to the fundus and opened without difficulty.The initial cavity width measurement was 2.5 cm.Attempts were made to adjust the device to allow the array to expand further, but the width increased only to 2.5 cm.The first cavity integrity assessment failed, a second assessment was performed and subsequently passed.Ablation was then completed with a total treatment time of 46 seconds.After removal of the device, the ablation effect was evaluated.On second inspection, the uterine cavity appeared not to have been ablated, however, the cervical canal showed signs of charring.The patient is doing well and was counseled regarding cervical stenosis and plans to follow up in a few months to assess procedural success.No other information is available.

• Brand Name: NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRAIL
• 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
• MDR Report Key: 24307458
• Report Number: 1222780-2026-00048
• Device Sequence Number: 9679758
• 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,Followup
• Report Date (Section B): 02/19/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: Not provided; 02/17/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/10/2026; 02/19/2026
• 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
• Patient Sex: Unknown