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

Model Number	2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Fever (1858); Pulmonary Edema (2020); Sepsis (2067); Vomiting (2144); Malaise (2359)
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
Hologic received a case report named ¨sepsis after bipolar radiofrequency endometrial ablation¨ published in the obstetrics & gynecology journal in august 2009.The exact date of the event is unknown in 2009.The case was a perimenopausal woman underwent an endometrial ablation using a bipolar radiofrequency device.She presented 36 hours postoperatively with sepsis.Her condition worsened despite 18 hours of intravenous antibiotics and aggressive fluid resuscitation, and she underwent exploratory laparotomy and hysterectomy.Blood cultures and uterine tissue cultures grew escherichia coli.The patient improved quickly after hysterectomy.The patient was reported as healthy, perimenopausal that received an unremarkable ablation cycle, blood loss was minimal and no antibiotic prophylaxis was administered.Patient had a negative endometrial biopsy and pap test performed 6 weeks before the procedure.Patient presented to the urgent local care 36 postoperatively with fever, chills, vomiting, diarrhea, and general malaise.Temperature was 102.3 with blood pressures around 80s/40s.Blood cultures were obtained and the patient was given intravenous doses of clindamycin, gentamicin, and cefazolin in addition to intravenous fluids.Patient was transferred for further management.In the emergency department, the patient¿s blood pressure was 83/62, pulse was 102, and sao2 was more than 92% on 3 l/min oxygen by nasal cannula.A computed tomography scan of the abdomen and pelvis revealed a small amount of gas and fluid contained within the endometrium, consistent with recent instrumentation.There was no myometrial gas, hematoma, abscess, or visceral perforation.Laboratory test results showed a white count of 10.3, hemoglobin 12.4, and platelets 81,000 (no history of thrombocytopenia).A comprehensive metabolic panel and cardiac enzymes were within normal limits.On admission, clindamycin and gentamicin were continued and vancomycin was added.During the 10 hours after admission, 14 l of intravenous fluid was required to maintain blood pressures in the 80s¿100s/50s¿60s.By the next morning, the patient¿s oxygen requirement increased to 10 l/min via 100% nonrebreather and she remained hypotensive.The white blood cell count increased to 14.6, and platelets fell to 59,000.Given the patient¿s worsening clinical status despite intravenous antibiotics and fluid resuscitation, the decision was made to proceed to the operating room for exploratory laparotomy and hysterectomy.At the time of laparotomy, the uterus was erythematous and boggy to palpation, but no other abnormalities were noted.There was no evidence of uterine perforation or bowel injury.The patient remained hemodynamically stable throughout the procedure.She was transferred postoperatively to the intensive care unit, intubated and sedated.Blood cultures were ultimately positive for escherichia coli, sensitive to the antibiotic regimen the patient had received.Uterine tissue culture was also positive for e.Coli.Final pathology revealed chronic cervicitis, thermal injury, acute myometritis, and acute salpingitis.Postoperatively, the patient improved quickly.She required no pressors and only maintenance intravenous fluids.Because of signs of pulmonary edema, she remained intubated until postoperative day 2.She was discharged from intensive care on postoperative day 3 and discharged home on postoperative day 5 with a peripherally inserted central catheter line in place to complete a 14-day course of ertapenem, which was selected for its once-daily dosing regimen with appropriate bacterial coverage.

• 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: 24349327
• Report Number: 1222780-2026-00058
• Device Sequence Number: 9986991
• Product Code: MNB
• UDI-Device Identifier: 15420045501133
• UDI-Public: 15420045501133
• Combination Product (Y/N): N
• 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): 02/16/2026

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: 2007
• Device Catalogue Number: NS2007US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/16/2026
• 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; Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown