BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC

    MDR report key: 17886446 · Received October 5, 2023

    Report

    Report Number
    MW5146662
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 2, 2023
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEVICE HAD TOO MUCH TORQUE WHEN FOOT PEDAL WAS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966755 HOLOGIC HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 23C21RA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown