BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT SWIVEL COLLIMATOR

    MDR report key: 3972768 · Received July 17, 2014

    Report

    Report Number
    1450503-2014-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SUMMIT INDUSTRIES, LLC
    Product Code
    IZX
    PMA / PMN Number
    K874687
    Removal / Correction Number
    Z-1216/1218-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COLLIMATOR IDENTIFIED IN THIS REPORT WAS THE SUBJECT OF A RECALL (NUMBERS Z-1216/1218-2007) INITIATED ON MAY 22, 2007 FOR THIS SAME PROBLEM. THIS COLLIMATOR WAS SOLD TO A DISTRIBUTOR WHO WENT OUT OF BUSINESS PRIOR TO THE RECALL. THERE WERE OVER 3000 COLLIMATORS INVOLVED IN THE RECALL AND TODAY ALL THAT MAY BE REMAINING IN USE ARE BETWEEN 13 AND 21 YEARS OLD. BETWEEN JULY 2007 AND JANUARY 2010 SUMMIT INDUSTRIES MADE A BEST FAITH EFFORT TO LOCATE AND REPAIR AS MANY OF THESE COLLIMATORS AS POSSIBLE. DUE TO THE AGE OF THE COLLIMATOR WE WERE NOT ABLE TO LOCATE ALL. SUMMIT'S FINAL REPORT WAS SUBMITTED TO THE FDA ON JANUARY 18, 2010 AND THE RECALL WAS REPORTED "TERMINATED" IN A LETTER (RECEIVED BY SUMMIT INDUSTRIES) FROM THE FDA IN MARCH OF 2010.

    Description of Event or Problem · 1

    A SUMMIT SWIVEL COLLIMATOR, MODEL # D800, FELL FROM TUBE STAND AND CONTACTED THE LEG OF A PT. PT WAS EXAMINED BY A HEALTHCARE PROFESSIONAL AND RELEASED. NO ADDITIONAL TREATMENT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420027 SUMMIT SWIVEL COLLIMATOR BEAM LIMITING DEVICE, IZX (892-1610) IZX SUMMIT INDUSTRIES, LLC D800

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR