BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA

    MDR report key: 5155768 · Received October 16, 2015

    Report

    Report Number
    5155768
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MIZUHO OSI ORTHOPAEDIC SURGERY TABLE EXPERIENCED A CRACKED CONNECTION BOX. IT APPEARS THAT THE PLASTIC BOX THAT HOLDS THE CONNECTOR ON THE HANA TABLE EASILY BROKE. THE CRACKS SEEM LIKELY TO BE DUE TO THE LONG CABLE END CONNECTOR THAT ATTACHES TO BOX AND ACTS AS A LEVER APPLYING PRESSURE TO THE BOX. MANUFACTURER RESPONSE FOR ORTHOPAEDIC SURGERY TABLE, MIZUHO OSI HANA ORTHOPAEDIC SURGERY TABLE (PER SITE REPORTER): AS OF THIS REPORT, THE MANUFACTURER HAS NOT RESPONDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685967 HANA ORTHOPAEDIC SURGERY TABLE JEB MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER DEVICES USED