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

Model Number FLT-112

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Serial number of the disposable device not provided by the complainant.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).

Event Description

It was reported that during a 3cm fibroid removal using the fluent fluid management system there was initially difficulty distending the cavity and the cervical seal became compromised.Fluid was leaking from the cervix and filling the under buttock drape causing the fluid deficit to rise.The physician removed the hysteroscope and the pump was stopped while he attempted to gain access to the cervix again.The scope was reinserted and a second tenaculum was used to seal the cervix.Distention improved and tissue resection began.About 80-90% of the fibroid was removed when a loud pop was heard and it was noted that the "tissue sock exploded and fluid and specimen fell to the floor." the tissue sock was exchanged as well as the waste bag.The procedure was terminated at a fluid deficit of 1467ml.A telfa was used to retrieve the remaining specimen that was on the floor.No injury or misdiagnosis was reported.

• 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: 8441287
• MDR Text Key: 140004125
• Report Number: 1222780-2019-00060
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2019

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-112
• Device Catalogue Number: FLT-112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/21/2019
• 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