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

Model Number	V5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the physician used the myosure lite device prior to the novasure procedure on (b)(6) 2026.During a novasure procedure that physician inserted that novasure device but could not get the array to open.The physician reseated the device four to five times.Blood was noted in the width dial.The physician then opened the second novasure device but unable to get the width dial out of red.The physician did a lot of back and forth and side to side movements.After trying to reseat it two to three times, it popped open, but the physician felt it was too wide.The physician inserted the scope to view cavity and identified a uterine perforation.Upon laparoscopy, which was already planned for salpingectomy, confirmed uterine perforation.The physician then used a ligasure generator to cauterize perforation site.It was confirmed that the second novasure device caused the perforation.The procedure was aborted.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.

• 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: 50227419
• Report Number: 1222780-2026-00499
• Device Sequence Number: 16026499
• Product Code: MNB
• UDI-Device Identifier: 15420045514300
• UDI-Public: (01)15420045514300(17)271027(10)25K07RA
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/12/2026

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: V5
• Device Catalogue Number: NSV5KITUS-001
• Device Lot Number: 25K07RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown