BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENT FLUID MANAGEMENT SYSTEM

    MDR report key: 12196344 · Received July 20, 2021

    Report

    Report Number
    1222780-2021-00198
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    July 5, 2021
    Report Date
    July 20, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIG
    UDI-DI
    15420045507401
    PMA / PMN Number
    K180825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. TWO DEVICES WERE INVOLVED IN THIS EVENT REPORTED UNDER: 1222780-2021-00199.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON JULY 5TH, THE OUF-FLOPAK BROKE APART. NO PATIENT INJURY REPORTED. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096159 FLUENT FLUID MANAGEMENT SYSTEM INSUFFLATOR, HYSTEROSCOPIC HIG HOLOGIC, INC. FLT-112S 20M18RKK 15420045507401

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUENT CONSOLE