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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC
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HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Model Number FLT-112S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
Event Type  malfunction  
Event Description
Patient to operating room for gyn procedure requiring use of fluent irrigation machine for hysteroscopy portion; when machine hooked up, the yellow cassette which is made of hard plastic was popped into the machine properly, but when the machine was activated the yellow cassette itself burst open and the internal mechanism disintegrated, many pieces flying out and scattering onto the floor.The fluent machine was replaced along with the tubing and cassettes.The procedure proceeded well from there.No harm came to patient.
 
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Brand Name
FLUENT FLUID MANAGEMENT SYSTEM
Type of Device
INSUFFLATOR, HYSTEROSCOPIC
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key11999082
MDR Text Key256209724
Report Number11999082
Device Sequence Number1
Product Code HIG
UDI-Device Identifier15420045507401
UDI-Public(01)15420045507401(17)240215(10)21B15RC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberFLT-112S
Device Catalogue NumberFLT-112S
Device Lot Number21B15RC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/08/2021
Event Location Hospital
Date Report to Manufacturer06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24820 DA
Patient Weight56
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