BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENT FLUID MANAGEMENT SYSTEM

    MDR report key: 13943400 · Received March 29, 2022

    Report

    Report Number
    1222780-2021-00057
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Report Date
    March 29, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIG
    UDI-DI
    15420045507401
    PMA / PMN Number
    K180825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS REPORT WAS SUBMITTED UNDER THE WRONG NUMBER: 1222782-2021-00057, PLEASE REFER TO THE CORRECT NUMBER 1222780-2021-00057.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FLUENT PROCEDURE, THE OUT-FLOPACK HOUSING BROKE APART IN PIECES. NO INJURIES TO THE PATIENT OR STAFF WERE REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2902382 FLUENT FLUID MANAGEMENT SYSTEM INSUFFLATOR, HYSTEROSCOPIC HIG HOLOGIC, INC. FLT-112S 20K28RF 15420045507401

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other