BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS ACMI

    MDR report key: 24789491 · Received April 6, 2026

    Report

    Report Number
    24789491
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 3, 2026
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ROOM SET TESTED D AND C MACHINE WAS WORKING. PATIENT IN ROOM TUBING CONNECTED SUCTION WOULD STOP BETWEEN YELLOW AND GREEN MARKING. CAPS REPLACED ON CANISTERS, CANISTERS REPLACED, TUBING REPLACED. DR [REDACTED] PROCEEDED USED ULTRASOUND PROCEDURE COMPLETED. INFORMED CHARGE NURSE [REDACTED] OF ISSUES EDUCATOR [REDACTED CAME IN ROOM TO HELP. TUBING PLACED IN BIOHAZARD BAG TOLD TO DISCARD. COLLECTION SET DISPOSABLE REF #23116, LOT S240174920, GYRUS ACMI. DEVICE TO BE CHECKED. MANUFACTURER RESPONSE FOR COLLECTION SET, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400435 GYRUS ACMI CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES) HHK GYRUS ACMI, LLC 23116 S240174920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other