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

Model Number	NS2013US
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a novasure procedure on (b)(6) 2025, the patient experienced a labial burn.No other information available.
Additional Manufacturer Narrative
Additional information received: physician was using the novasure for the ablation when he noted that the patient had a white line described as a ¨labial burn¨.No degree could be suggested by the physician.The physician treated the area with silvadene cream.No other information available.
Additional Manufacturer Narrative
Device was returned for investigation : visual inspection was conducted, and there were no signs of physical damage.The fluid reached the desiccant filter.Functional testing was conducted and the cia test failed, then a leak test was conducted and no leaks were noticed, the filters were replaced and the cia test passed.Additionally, the test record of the serial number and the risk management file were reviewed, the device was released meeting all the specifications and the failure mode was properly documented in the rsk file.In addition, there have been no design changes to the external sheath.Hence, the complaint cannot be confirmed.However, a new failure mode was observed "filters occluded".This observation will be monitored and trended.¿¿.

• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21231599
• Report Number: 1222780-2025-00036
• Device Sequence Number: 18293460
• Product Code: MNB
• UDI-Device Identifier: 15420045501119
• UDI-Public: (01)15420045501119(17)261029(10)24K09RJ
• 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,Followup
• Report Date (Section B): 03/28/2025

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: NS2013US
• Device Catalogue Number: NS2013US
• Device Lot Number: 24K09RJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 01/24/2025; 02/27/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/03/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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