BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC

    MDR report key: 24531908 · Received March 6, 2026

    Report

    Report Number
    24531908
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 7, 2026
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MD WAS PERFORMING A PAP SMEAR. THE BROOM BROKE AS THE MD ATTEMPTED TO BRUSH CERVIX-LEAVING THE BRISTLES INSIDE OF PATIENT'S CERVIX. THE BRISTLES WERE SUCCESSFULLY REMOVED WITH RING FORCEPS. NO CERVICAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590648 HOLOGIC SPATULA, CERVICAL, CYTOLOGICAL HHT COOPERSURGICAL, INC. 908006 283393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other