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

Model Number	FLT-112S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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.
Event or Problem Description
It was reported that during a fluent procedure on (b)(6), the out-flopak cracked during the initial prime cycle of the console.No harm to the patient or staff reported.No other information is available.
Additional Manufacturer Narrative
Hologic has performed a health risk assessment based on the failure mode related to out-flopaks broken//damaged and the probability of occurrence for the possible harms was determined to be acceptable.No injuries, diseases or death have been reported, the failure mode is not likely to result in a death, serious injury or to cause adverse health consequences to the patient.Hologic has determined this event as not reportable and will cease reporting based only on this failure mode.Hologic will continue to monitor and trend this failure mode.In case of any serious injury or harm to the patient, hologic will trigger the resumption of mandatory reporting per 21 cfr 803.18.The last report submitted for this failure mode is recorded under 1222780-2022-00122.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 14282452
• Report Number: 1222780-2022-00122
• Device Sequence Number: 11976735
• Product Code: HIG
• UDI-Device Identifier: 15420045507401
• UDI-Public: (01)15420045507401(17)250125(10)22A26RB
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2025
• Device Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Device Lot Number: 22A26RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUENT CONSOLE.
• Patient Sex: Female