MAUDE Adverse Event Report: HOLOGIC, INC FLUENT PRO 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	Bradycardia (1751)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported 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 the procedure on (b)(6) 2025, the deficit was increasing rapidly.Although the pressure was constant at about 80 mmhg, the perception is that it might have been higher.The patient suffered from bradycardia and for a moment the pulse was lost.When the team proceeded to execute the reanimation protocol, the tubing ruptured from the cartridges and caused the fluid to leak out of the circuit and the tubing was agitating vigorously.The patient was reanimated.After having the patient stabilized, a leak was discovered at the patient's bed side and was coming from the distal end of the scope.About 500 ml of fluids was observed.The drape with integrated drainage pocket was being used.Abnormal sounds were also reported for a week from the pump.The system used in later cases worked normally without any issues apart from the foot pedal difficult to operate.The pressure seemed way higher during the case in the patient than what showed on the pump.Liquid was spelling all over the place.The flow pack broke due to pressure and the irrigation tubing detached at the bottom of the flow pack and spilled everywhere.Patient bradycardia dropped around 20 beats per minute, and it was able to be stabilized.On (b)(6), the calibration test was run, and the test was off by 30-40 g.After zeroing the load cell and retesting the results were correct and the pressure calibration test was also correct.No other information is available.
Additional Manufacturer Narrative
The brand name is fluent pro fluid management system.

• Brand Name: FLUENT PRO 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: simran keswani ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 23556434
• Report Number: 1222780-2025-00575
• Device Sequence Number: 21345415
• Product Code: HIG
• UDI-Device Identifier: 15420045516212
• UDI-Public: (01)15420045516212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 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: 10/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown