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

Model Number FLT-112S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review and sterile lot review were unable to be conducted for the disposable device as the lot number was not provided by the complainant.Internal complaint reference: (b)(4).The fluent system was returned for evaluation and passed all functional testing.

Event Description

It was reported that when using the fluent system a reprime had to be completed because the waste bag hooks didn't sense the bag, and the system was alarming with the screen flickering between "reprime" and "operating".During cutting it was noted that water was dripping from the tissue canister and the specimen was coming out of the sock and plugging up the mesh.Due to the weight and pressure the canister broke off and the fluid and specimen spilled to the floor.The canister was not able to be used since the specimen had plugged the mesh holes and a basin was used to catch the outflow and the specimen was then strained out.The fluent system was replaced.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8370311
• MDR Text Key: 137417597
• Report Number: 1222780-2019-00039
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/29/2019

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: FLT-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1