MAUDE Adverse Event Report: HOLOGIC, INC FLUENT CONSOLE; INSUFFLATOR, HYSTEROSCOPIC

Model Number	FLT-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Sepsis (2067); Septic Shock (2068); Cardiogenic Shock (2262)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Serial 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 a patient received a novasure procedure on (b)(6) 2026, the physician reported that the patient had ¨different¨ anatomy and called a partner as well as an ultrasound tech to assist.Ablation was completed and a hysteroscopy using a fluent and omni scope was performed pre and post ablation with no issues to note nor increase in deficit with the fluent machine.Patient did not had an endometrial biopsy prior procedure so the physician performed a dilation and curettage in the operating room.Pathology came back with results as acute chronic inflammation.On (b)(6) the patient complained of abdominal pain for which different medications were given at the time.On (b)(6) 2026 the patient presented to the emergency department with pain and confusion.Lactate was 6.7 and blood pressure per hospital was ¨38/15¨.Patient received an exploratory laparoscopy and when the trocars were inserted puss was oozing and the abdomen of the patient was full of puss.No thermal injury was observed and a spot in the cornual area was observed to have fat pressed against the uterus.Patient was too delicate to perform a hysterectomy and was intubated and brought to the icu on antibiotics and vasopressors and the physician reported she was very sick and might not pull through.Patient was reported as being in cardiogenic shock and controlled.A swap from the cervix was performed and came back as e.Coli.Patient had a history of 3 c-sections.A bladder injury was ruled out.Additional information was later received, the patient stayed in the intensive care unit for a few days before being admitted to the normal floor.The patient was later scheduled for a robotic hysterectomy with an exploratory laparotomy on (b)(6) 2026, the patient made a successful recovery and was still being treated for the infection.
Additional Manufacturer Narrative
Additional information received: the patient has been home for a few weeks and declined patient rehabilitation.There is a nurse that comes a few times a week to help with the rehabilitation.It was reported that the patient is dealing with an emotional trauma because of the incident.No other information is available.

• Brand Name: FLUENT CONSOLE
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• 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: 24348927
• Report Number: 1222780-2026-00056
• Device Sequence Number: 4927249
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: 15420045508552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K180825
• 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): 03/05/2026

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: FLT-100
• Device Catalogue Number: FLT-100
• 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: 02/26/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown