BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLE, SURGICAL

    MDR report key: 5131066 · Received October 7, 2015

    Report

    Report Number
    5131066
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    June 25, 2015
    Report Date
    September 18, 2015
    Manufacturer
    MIZUHO AMERICA, INC
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS POSITIONED ON FRACTURE TABLE IN THE OPERATING ROOM. THE RIGHT FOOT WAS PLACED IN TRACTION BY DOCTOR, THE LEFT LEG WAS PLACED IN STIRRUP. THE CENTER OF THE FRACTURE TABLE WAS REQUESTED BY DOCTOR TO BE REMOVED. I TOLD HER THAT I WAS NOT AWARE OF THE PROCEDURE TO ACCOMPLISH HER REQUEST. DOCTOR INSTRUCTED ME TO REMOVE A PIN FROM THE FOOT OF THE TABLE, I ASKED IF SHE WAS SURE THAT THE PIN WAS VERY SECURE. SHE THEN INSTRUCTED ME TO STRAIGHTEN THE PIN RELEASE AND PULL THE PIN. I ASKED AGAIN IF SHE WAS SURE. SHE SHOWED ME THE MOTION REQUIRED. I PULLED THE PIN AND THE MAIN SUPPORT TO THE TABLE DROPPED DOWN TO THE FLOOR OF THE TABLE. SEVERAL STAFF IN THE ROOM ASSISTED IN REPLACING THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662454 TABLE, SURGICAL JEA MIZUHO AMERICA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR