BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR

    MDR report key: 2578125 · Received May 11, 2012

    Report

    Report Number
    9612638-2012-00004
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    April 17, 2012
    Report Date
    April 17, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC
    Product Code
    JAQ
    PMA / PMN Number
    K011657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NATURE OF THE DESIGN IS THE ROOT CAUSE. THE FIT BETWEEN THE BORE IN THE ACETAL PADDLE AND THE STAINLESS STEEL ROD IS NOT LIQUID-TIGHT; IT IS A LIGHT INTERFERENCE FIT, AND THE PADDLE IS HELD IN PLACE BY SEVERAL CROSS PINS. A CORRECTIVE ACTION TO INFORM THE CUSTOMER TO CEASE USE OF THE RECTAL RETRACTOR (B)(4) IS IN PREPARATION AND WILL BE REPORTED UNDER THE GUIDELINES OF 21CFR PART 806. THIS REPORT IS BASED ON INFO RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MED SYS. WHILE THE REPORTED EVENT IS BEING INVESTIGATED, SOME OF THE FACTS ARE AS YET UNVERIFIED. NO FURTHER F/U TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    IT WAS NOTICED BY A VARIAN EMPLOYEE THAT THE DESIGN OF THE RECTAL RETRACTOR ((B)(6)) FROM THE STAINLESS STEEL RING AND TANDEM COMBINATION APPLICATOR SETS ((B)(6)) HAS THE POSSIBILITY THAT CONTAMINATES, OR FLUIDS, COULD ENTER INTO THE CTR OF THE RECTAL RETRACTOR PADDLE THROUGH THE CROSS PINS OR BOTTOM ROD AREAS. USING A PART IN THIS CONDITION COULD RESULT IN INFECTION, TOXICITY, OR ALLERGIC REACTION. THERE HAVE BEEN NO CUSTOMER REPORTS OF CONTAMINATION. THE BASIS FOR THIS MANDATORY REPORT IS AN INVESTIGATION BY A VARIAN EMPLOYEE. RELATED REPORTS: 9612638-2012-00002, 00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other