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

Model Number FLT-112S

Device Problems Break (1069); Output Problem (3005)

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

Event Date 05/17/2021

Event Type  malfunction  

Event Description

Before the surgical case in the operating suite, priming of the fluid management device failed because yellow cartridge broke apart.No injury to the patient.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 12040494
• MDR Text Key: 257479562
• Report Number: 12040494
• 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: 06/16/2021

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-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: 21824R
• 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: 06/16/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1