BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOWFIN STIRRUP

    MDR report key: 8349403 · Received February 19, 2019

    Report

    Report Number
    8349403
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    December 20, 2018
    Report Date
    February 13, 2019
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING ROBOTIC PORTS, RIGHT STIRRUP HINGE BROKE AND FELL TO THE GROUND WHILE THE PATIENT WAS IN FULL TRENDELENBERG POSITION. SURGICAL TECH PICKED UP PATIENT'S LEG AS SOON AS POSSIBLE AND ATTENDING SURGEON WAS NOTIFIED. RIGHT STIRRUP WAS REPLACED. EVALUATION OF THE DEVICE SHOWED THAT ONE OF THE PINS THAT ENGAGES THE LOCKING MECHANISM WAS MISSING AND THE OTHER PIN WAS BACKED OUT OF THE HOLE ENOUGH TO DISENGAGE, CAUSING THE LEG HOLDER TO FALL. NO PATIENT INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142644 YELLOWFIN STIRRUP SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA