BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIRRUP

    MDR report key: 6124710 · Received November 23, 2016

    Report

    Report Number
    6124710
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 28, 2016
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN STIRRUPS FOR COLONOSCOPY PROCEDURE. DURING THE CASE, THE RIGHT STIRRUP WITH THE PATIENT'S RIGHT LEG IN THE STIRRUP, FELL. STAFF MEMBER IMMEDIATELY LIFTED THE LEG MANUALLY UP WHILE THE LEG WAS STILL IN THE STIRRUP. THE STIRRUP WAS NOTED TO BE BROKEN AT THE JOINT AND BENT WHERE THE STIRRUP ATTACHED TO THE BED. A NEW STIRRUP RETRIEVED BY A STAFF MEMBER WAS PLACED ON THE BED WITHOUT DIFFICULTY. THE PATIENT DID NOT EXPERIENCE ANY ILL EFFECTS FROM THIS EVENT AND WAS DISCHARGED SHORTLY AFTER SURGERY (1 DAY LATER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775390 STIRRUP OPERATING ROOM ACCESSORIES TABLE TRAY FWZ ALLEN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR UNKNOWN.