BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOFIN STIRRUP

    MDR report key: 8252568 · Received January 16, 2019

    Report

    Report Number
    8252568
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    October 24, 2018
    Report Date
    December 21, 2018
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS POSITIONED IN SURGERY FOR A LAPAROSCOPY. LEGS WERE IN YELLOW FIN STIRRUPS. PROCEDURE HAD STARTED WHEN ALL OF A SUDDEN PATIENT'S RIGHT LEG IN THE STIRRUP FELL DOWN TO THE SIDE OF TABLE. LEG WAS CAUGHT BY DR. AND HELD BY NURSES. UPON INSPECTION OF PATIENT'S RIGHT LEG NO INJURY WAS NOTED PER DR. THE STIRRUP WAS THEN INSPECTED AND WAS FOUND TO COMPLETELY HAVE SNAPPED OFF AT METAL ATTACHMENT TO STIRRUP. UPON INSPECTION OF THE FLOOR A PIECE OF THE METAL SCREW WAS ALSO FOUND AND TAPED TO THE STIRRUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48048 YELLOFIN STIRRUP SUPPORT, PATIENT POSITION CCX ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13140 DA