BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 5130881 · Received September 22, 2015

    Report

    Report Number
    1825014-2015-00044
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 22, 2015
    Manufacturer
    AMATECH
    Product Code
    EYD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL CASE, A PATIENT'S LEG WAS IN A LEVITATOR STIRRUP WHEN THE STIRRUP SPRING UPWARDS. NO INJURIES WERE REPORTED. STAFF HELD THE STIRRUP IN PLACE AND THE SURGERY WAS ABLE TO BE COMPLETED. THE FACILITY IS RETURNING THE STIRRUP TO SKYTRON FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625720 SKYTRON LEVITATOR STIRRUP EYD AMATECH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other