BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOTOPUS-FLASH

    MDR report key: 24381113 · Received February 18, 2026

    Report

    Report Number
    MW5184042
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 24, 2026
    Report Date
    February 12, 2026
    Manufacturer
    KITAZATO CORPORATION
    Product Code
    MQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CAPPED VITRIFICATION DEVICE (CONTAINING A PATIENT'S BLASTOCYST) WAS MOVED AND RELEASED INTO A GOBLET WHILE SUBMERGED UNDER LIQUID NITROGEN. THE DEVICE UNEXPECTEDLY SEPARATED FROM THE COVER (CAP) AND POPPED OUT OF THE LIQUID NITROGEN AND ONTO THE FLOOR. THE COVER (CAP) REMAINED IN THE LIQUID NITROGEN. THE PATIENT'S BLASTOCYST COULD NOT BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445847 CRYOTOPUS-FLASH LABWARE, ASSISTED REPRODUCTION MQK KITAZATO CORPORATION S41224

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other