BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUNTER BALANCE KERATOMETER

    MDR report key: 2462537 · Received February 13, 2012

    Report

    Report Number
    MW5024268
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 13, 2012
    Manufacturer
    MARCO OPHTHALMIC INC.
    Product Code
    HJB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MARCO OPHTHALMIC 1290 ENCORE STANDS ACCESSORY ARM - COUNTER BALANCED KERATOMETER ARM MODEL 1204 - HAVE THE POTENTIAL FOR PINCHING THE ELECTRICAL WIRING CAUSING SPARKS NEAR PATIENTS. THE MFR HAS STATED THAT THIS ISSUE IS NOT COVERED IN WARRANTY REPAIR BECAUSE THE OPEN WIRE HAS BEEN CAUSED BY A PINCH AND NOT DUE TO A MFG FLAW. THE WIRE RESTS IN THE JOINT OF THE ARM WHERE THE PINCHING TAKES PLACE IN NORMAL OPERATION OF THE ARM ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUNTER BALANCE KERATOMETER COUNTER BALANCE KERATOMETER HJB MARCO OPHTHALMIC INC. 1204

    Patients

    Seq Age Sex Outcome Treatment
    1