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

Model Number FLT-112S

Device Problems Material Fragmentation (1261); Material Separation (1562)

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

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.5 fluent disposables were used in this case please refer to: 1222780-2021-00142, 1222780-2021-00143, 1222780-2021-00144, 1222780-2021-00146.

Event Description

It was reported that during a fluent procedure the out-flopack of the disposable cracked open.No patient injury was reported.No other information is available.

Manufacturer Narrative

Fluent disposable was received, visual inspection was performed and had no kinks and out-flopack was disassembled.No functional testing was executed.The complaint can be confirmed.This observation will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• 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: 12021567
• MDR Text Key: 260984868
• Report Number: 1222780-2021-00145
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 15420045507401
• UDI-Public: (01)15420045507401(17)240128(10)21A28R
• Combination Product (y/n): N
• PMA/PMN Number: K180825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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 Expiration Date: 01/28/2024
• Device Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: 21A28R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUENT CONSOLE; FLUENT FLUID MANAGEMENT SYSTEM FLT-112S (4)
• Patient Outcome(s): Other