BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARIFIX

    MDR report key: 19522227 · Received June 12, 2024

    Report

    Report Number
    3006345872-2024-00006
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 14, 2024
    Report Date
    December 4, 2024
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    GEH
    UDI-DI
    00850002250404
    PMA / PMN Number
    K190356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: D4, D9, H3, H6 DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CRYOGEN DELIVERY AT THE USER FACILITY THE DEVICE COULD NOT BE SHUT OFF, POTENTIALLY EXPOSING THE PATIENT TO EXCESSIVE CRYOGEN DELIVERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CRYOGEN DELIVERY AT THE USER FACILITY THE DEVICE COULD NOT BE SHUT OFF, POTENTIALLY EXPOSING THE PATIENT TO EXCESSIVE CRYOGEN DELIVERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136419 CLARIFIX CRYOSURGICAL UNIT AND ACCESSORIES GEH ENTELLUS MEDICAL, INC. 23212193 00850002250404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown