BEUDAMED
    FDA Adverse Event Summary report: N

    ZEE

    MDR report key: 74123 · Received March 6, 1997

    Report

    Report Number
    MW4001795
    Date Received
    March 6, 1997
    Report Date
    March 27, 1996
    Manufacturer
    MARCO OPTHALMIC. INC.
    Product Code
    HRJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TABLE TOP WAS BECOMING INCREASINGLY DIFFICULT TO MOVE LONGITUDINALLY. A LONG SCRAPE WAS EVIDENT JUST UNDER THE TABLE TOP THAT PARALLELED THE TABLE RANGE OF TRAVEL. TABLE SUPPORTS A VISION TESTER, AUTO-REFRACTOMETER AND A NON-CONTACT KERATOMETER. INSPECTION FOUND THE TABLE TOP RAIL ROLLER SURFACE HAD BENT FROM A 90 DEGREE ANGLE TO ABOUT 120 DEGREE. THE DIFFICULTY IN TABLE TOP TRAVEL AND THE SCRAPE WERE A RESULT OF THE BENT RAIL. WITH THE RAIL REMOVED, A THREE FOOT GROOVE WAS WORN LONGITUDINALLY INSIDE THE ALUMINUM RAIL. MOST OF THE EQUIPMENT WEIGHT WAS DISTRIBUTED TOWARDS THE PT'S SIDE OF THE TABLE. THIS IMBALANCE PUT CONSTANT UPWARD PRESSURE ON TWO STEEL ROLLERS ON WHICH THE RAIL TRAVERSED, ONE OF WHICH OVER TIME WORE THE GROOVE INTO THE RAIL. THE RAIL WORE TO THE POINT THAT IT EVENTUALLY BEGAN TO BEND. IF NOT IDENTIFIED IN TIME THERE IS A POTENTIAL FOR THE TABLE TOP TO TIP OVER, DUMPING THE EQUIPMENT TO THE GROUND OR WORSE INTO A PT'S LAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEE OPHTHALMIC TRANSLATING TABLE HRJ MARCO OPTHALMIC. INC. TS-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *