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

Model Number FLT-112S

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

From staff: surgeon was using myosure device with fluent fluid management system.Machine was loud, and sounded as though it was working harder than normal.Deficit jumped to 500ml soon after surgeon started to use it.Staff looked for leak at perineal site but was unable to find one.Surgeon was going to stop procedure due to possible perforation of uterus.Leak was discovered at the site of the cartridge placed on machine.It was then determined that the fluent device was faulty, we changed to a new system and deficit was at 20 once scope was reintroduced.Surgeon was able to use myosure device and remove the fibroid.From operative report: the first myosure cassette did not function, and so this was exchanged for a new cassette.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 18920503
• MDR Text Key: 337868054
• Report Number: 18920503
• 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: 02/27/2024

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: Health Professional
• Device Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: 23L23RB
• 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: 02/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 67 KG