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

Model Number LBL-06324 REV 006

Device Problems Material Fragmentation (1261); Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2023

Event Type  malfunction  

Event Description

When putting the outflow cartridge on the fluent machine, the yellow cartridge would not snap into place.Many efforts of trying to seat the cartridge properly.I seated it the best that i could and when i started the priming process, it literally busted apart into several pieces.We opened another fluid management system and the outflow cartridge easily snapped into place.

• 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: 16852756
• MDR Text Key: 314380307
• Report Number: 16852756
• 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: 04/26/2023

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: LBL-06324 REV 006
• Device Lot Number: 22M09RA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1