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

Model Number	FLT-112S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: fluent tubing for myosure device was not working.Myosure machine was malfunctioning in that suction function was not working.Rn sought help from (b)(6) charge who called rep for machine, advised changing tubing and keeping malfunctioning tubing for further investigation.Tubing suction not working, did not evacuate cavity while scope procedure was being done.Procedure was completed after new tubing was attached.Ref number for tubing flt-112s, lot 25g02ra exp date 7/1/28.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 23389744
• Report Number: 23389744
• Device Sequence Number: 13254310
• Product Code: HIG
• UDI-Device Identifier: 15420045507401
• UDI-Public: (01)15420045507401
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2025
• Report Date (Section F): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: 25G02RA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Date Report Sent to FDA: 10/07/2025