BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOTOP

    MDR report key: 23424244 · Received October 30, 2025

    Report

    Report Number
    23424244
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 3, 2025
    Manufacturer
    KITAZATO CORPORATION
    Product Code
    MQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PLUNGING THE LAST CRYOTOP DURING PATIENT'S EGG THAW, I COULD NOT LOCATE EGGS ON THE DEVICE IN MEDIA. I THEN NOTICED THAT THE TIP WHERE EGGS ARE NORMALLY LOADED WAS NOT ATTACHED TO THE DEVICE. I LOOKED AND NOTICED THE TIP WAS ATTACHED TO A PIECE OF PLASTIC STICKING TO THE FORCEPS USED TO REMOVE THE CAP FROM DEVICE. I AND ANOTHER EMBRYOLOGIST II TRIED PLUNGING THE PIECE OF PLASTIC AND TIP OF THE DEVICE IN THAW MEDIA TO TRY TO LOCATE EGGS, BUT NO EGGS WERE SEEN ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297124 CRYOTOP LABWARE, ASSISTED REPRODUCTION MQK KITAZATO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown