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

Model Number FLT-100

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2021

Event Type  malfunction  

Event Description

Hologic fluent hysteroscopic irrigation/ insufflation system was not functioning during case.The fluid in and out of the device was not working correctly.The fluent system had the be restarted a few times.

• Brand Name: FLUENT CONSOLE
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11946190
• MDR Text Key: 254509055
• Report Number: 11946190
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2021

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: No Information
• Device Model Number: FLT-100
• Device Catalogue Number: FLT-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2021
• Date Report to Manufacturer: 06/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA