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

Model Number FLT-100

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Event Description

Equipment issue: fluent fluid management system machine was not working.Manufacturer representative was present.Surgical team had opened one myosure supply and plugged everything into the machine as indicated but when the foot pedal was pressed it did not work.Team tried to open another myosure device to see if the first device was defective, but the second device did not work either with the machine.It was determined by the manufacturer representative that the machine was corrupt and was having internal errors likely from a more recent gyn case.Procedure continued and surgeon was aware the whole time.Machine was brought to the front desk after case so it could be taken in for repair.The manufacturer was notified and the machine was replaced entirely.The new machine was delivered on a different day closely following the event, and it worked well for the next scheduled case.There was no injury to the patient.

• Brand Name: FLUENT FLUID CONSOLE MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 10459173
• MDR Text Key: 204544009
• Report Number: 10459173
• 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: 08/25/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1