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

Model Number FLT-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

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.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Serial number of the device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.

Event Description

It was reported that after successful completion of the procedure, the patient got up to get dressed.Subsequently, the patient blood pressure was "very low" and the patient became unresponsive.Office staff called 911.The patient was transported to the emergency room for observation.Hologic representative states that due to a poor cervical seal and the switching out of multiple under buttocks drapes, the total fluid deficit is unknown.No additional details available at this time.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough, ma
• Manufacturer Contact: kelsea lyver ; 250 campus drive; marlborough, ma ; 2636130
• MDR Report Key: 9825348
• MDR Text Key: 183160168
• Report Number: 1222780-2020-00054
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FLT-100
• Device Catalogue Number: FLT-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPE, SN UNKNOWN; MYOSURE TRD, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Life Threatening; Other