BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA SURGICAL TABLE

    MDR report key: 7643029 · Received June 27, 2018

    Report

    Report Number
    2921578-2018-00024
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Report Date
    August 1, 2018
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE MECHANICAL FAILURE WAS DUE TO EXCESSIVE LOCK FORCE OF THE HANDLE BY USER. FIELD SERVICE ENGINEER EDUCATED STAFF/BIO MEDICAL ENGINEER ON NOT TO SURPASS THE 2:00 POSITION ON THE LOCK HANDLE.

    Description of Event or Problem · 0

    PT WAS HAVING ANTERIOR HIP REPLACEMENT SURGERY AND THE NON-OPERATIVE LEG FELL WHILE STILL IN THE LEG TABLE SUPPORT. THE DR DETERMINED THAT THE PT WAS NOT HARMED. MIZUHO OSI REPLACED THE PRESSURE ARM ASSEMBLY THAT WAS DAMAGED FROM THE LOCKING HANDLE EXCEEDING THE 2:00 POSITION.

    Description of Event or Problem · 1

    PT WAS HAVING ANTERIOR HIP REPLACEMENT SURGERY AND THE NON-OPERATIVE LEG FELL WHILE STILL IN THE LEG TABLE SUPPORT. THE DR DETERMINED THAT THE PT WAS NOT HARMED. MIZUHO OSI REPLACED THE PRESSURE ARM ASSEMBLY THAT WAS DAMAGED FROM THE LOCKING HANDLE EXCEEDING THE 2:00 POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485528 HANA SURGICAL TABLE SURGICAL TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6875

    Patients

    Seq Age Sex Outcome Treatment
    1