BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOWFINS

    MDR report key: 3080037 · Received March 29, 2013

    Report

    Report Number
    3080037
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THROUGHOUT PROCEDURE PATIENT WAS POSITIONED IN BILATERAL YELLOW FIN STIRRUPS WITH FOOT OF BED REMOVED. UPON COMPLETION OF SURGICAL PROCEDURE, THE RIGHT YELLOW FIN WAS SQUEEZED IN ORDER TO RAISE IT TO REPLACE FOOT OF BED. AT THIS TIME, WITH THE PATIENT'S LEG STILL IN THE STIRRUP, THE STIRRUP AND STIRRUP HOLDER FELL OFF THE BED. THE HANDLE OF THE STIRRUP HIT THE FLOOR AND THE CST IMMEDIATELY GRABBED THE LEG TO AVOID ANY ROTATION. WITH THE HELP OF THE RN AND CRNA, THE CST WAS ABLE TO REAPPLY THE STIRRUP HOLDER BACK ON THE BED, NOTING THE TIGHTENING KNOB WAS VERY LOOSE. THE HOLDER WAS SECURELY REAPPLIED AND THE STIRRUP WAS PLACED BACK IN THE HOLDER. THE PATIENT'S LEG WAS CAREFULLY REMOVED FROM THE STIRRUP ALONG WITH THE LEFT LEG WITH NO SIGN OF TRAUMA OR DEFORMITY. DR REQUESTED A PORTABLE RIGHT HIP XRAY TO BE TAKEN IN PACU WHICH WAS PERFORMED AND THE SURGEON WAS NOTIFIED OF THE INCIDENT AND FOLLOW-UP CARE. X-RAY WAS NEGATIVE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131379 YELLOWFINS STIRRUPS EYD ALLEN MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR