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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM PROCEDURE KIT; INSUFFLATOR, HYSTEROSCOPIC
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HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM PROCEDURE KIT; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Model Number FLT-112S
Device Problems Fracture (1260); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Event Description
During utilization of hologic fluent¿ fluid management system, the yellow casing of the fluent out-flopak receptacle fractured and projected off the console.After the out-flopak fracture, an unknown error message was displayed on the console.A new flopak had to be primed and utilized.This caused delays in the patient care but did not alter the outcome of the patient.Initially concerns of user error, if the previous case was not ended appropriately prior to new flopak tubing being connected.Staff confirmed that the previous case was ended and this was for a new case.No user error has been identified.
 
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Brand Name
FLUENT FLUID MANAGEMENT SYSTEM PROCEDURE KIT
Type of Device
INSUFFLATOR, HYSTEROSCOPIC
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key12421003
MDR Text Key269810714
Report Number12421003
Device Sequence Number1
Product Code HIG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/24/2021
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 Model NumberFLT-112S
Device Catalogue NumberFLT-112S
Device Lot Number21F04R
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/24/2021
Event Location Hospital
Date Report to Manufacturer09/03/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18250 DA
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