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

Model Number FLT-112S

Device Problem Communication or Transmission Problem (2896)

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

Event Date 06/24/2022

Event Type  malfunction  

Event Description

Fluent fluid management system wouldn't register with machine.Another one was opened and used without issue.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 15051778
• MDR Text Key: 296137908
• Report Number: 15051778
• 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: 07/11/2022

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 Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: 22EO5RC
• 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: 07/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1