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

Model Number FLT-100

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2024

Event Type  malfunction  

Event Description

Prior to bringing patient to the operating room (or), the circulating registered nurse (rn) and surgical scrub tech attempted to prime sterile tubing with saline, but was unable to prompt machine to next step due to yellow outflow unit not seating in the machine.Charge rn phoned hologic representative as to why the cartridge would not seat properly.Representative stated a light sensor in machine was not reading properly and to place a piece of white paper in front of sensor and then place cartridge.The cartridge seated, and the fluent machine was ready and prompting for the next step.Patient brought to or positioned in stirrups.Doctor ready to continue with flushing tubing so tech pushed next on screen to continue with setup process.The yellow cartridge outer casing exploded off releasing all inner components.Bits of the cartridge, screws, plastic was found by or front door.Last preventive maintenance was on april 2023.

• Brand Name: FLUENT CONSOLE
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 19018575
• MDR Text Key: 339099010
• Report Number: 19018575
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2024

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
• Device Operator: Other
• Device Model Number: FLT-100
• Device Catalogue Number: FLT-100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 106 KG
• Patient Race: White