BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLE ETHER SCREEN ACCESSORY

    MDR report key: 1951343 · Received January 6, 2011

    Report

    Report Number
    1043572-2011-00003
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    January 6, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS DISTRIBUTOR'S SERVICE REPRESENTATIVE INSPECTED THE ACCESSORY AND FOUND IT TO BE OPERATING PROPERLY; NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS ACCESSORY. BASED ON THE DESCRIPTION OF THE EVENT IT IS BELIEVED THAT THE CONTROL KNOB WAS NOT FULLY TIGHTENED PRIOR TO THE START OF THE PROCEDURE. THE COMPLAINT ANALYSIS DETERMINED THIS EVENT TO BE ISOLATED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE TABLE ACCESSORY (ETHER SCREEN) USED TO SUSPEND THE SURGICAL DRAPE IN FRONT OF THE PATIENT, SLOWLY SLIPPED DOWN AND THE ACCESSORY'S CONTROL KNOB IMPACTED THE PATIENT'S CHEEK, CAUSING A SMALL BRUISE. THE ACCESSORY WAS REPOSITIONED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS REPORTEDLY SOUGHT A FOLLOW-UP ASSESSMENT OF THE CHEEK AREA BY A SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TABLE ETHER SCREEN ACCESSORY OPERATING TABLE ACCESSORY FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other