MAUDE Adverse Event Report: HOLOGIC, INC FLUENT FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Model Number	FLT-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/27/2026
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 during a myosure and fluent procedure on (b)(6)2026, that the uterus was set and holding to 80 mmhg pressure and the deficit was normal.During resection of a large polyp, the deficit increased and the fluent system was extremely loud.The uterus holding pressure started to go down to around 60-70 mmhg.High fluid loss alert showed up on the screen.The physician noted no visible fluid leakage externally or from the cervix, and only a small amount of fluid around 200 ml was observed via ultrasound present in the abdomen.The physician went back with the scope and the same issue occurred where the high fluid loss error occurred ad the deficit was shooting up.The physician went back into the cavity inside with the scope and the machine was quieter but deficit was still rising.However, the fluid deficit continued to increase and high fluid loss alarms presisted.Due to the reccurrence of the issue and concern for a possible uterine perforation, the physician elected to perform laparoscopic evaluation.A second physician inserted a hysteroscope while laparoscopic visualization and performed to assess for perforation.No visible uterine perforation was identified, and no source of fluid loss was observed.The myosure procedure was discontinued and the case was completed using a curettage.No additional medical intervention reported.No other information is available.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• 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 ; CR 20102
• MDR Report Key: 25567155
• Report Number: 1222780-2026-00394
• Device Sequence Number: 10280476
• Product Code: HIG
• UDI-Device Identifier: 15420045516212
• UDI-Public: (01)15420045516212
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K240886
• 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): 06/19/2026

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: FLT-200
• Device Catalogue Number: FLT-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10-401FC
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown