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

Model Number FLT-112S

Device Problems Break (1069); Mechanics Altered (2984); Incomplete or Inadequate Connection (4037)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

Upon placing hologic fluent management system into the myosure machine, the yellow connective device was broken and not seating properly in the machine.

• 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: 16582550
• MDR Text Key: 311682224
• Report Number: 16582550
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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: 22K22RA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2023
• Date Report to Manufacturer: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA