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

Model Number FLT-112S

Device Problem Suction Failure (4039)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

Fluent system 368668 and fluent fluid management system ref (b)(4) malfunctioned by suction not working & fluid not running appropriately.System red bagged for quarantine.Inadequate suction noted, resulting in new tubing to be utilized.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM PROCEDURE KIT
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 12421004
• MDR Text Key: 269811095
• Report Number: 12421004
• 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: 08/23/2021

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: Health Professional
• Device Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: 21F04R
• 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: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA