BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLETCHER-SUITE DELCLOS STYLE APPLICATOR SET

    MDR report key: 3541743 · Received December 20, 2013

    Report

    Report Number
    9612638-2013-00018
    Event Type
    Other
    Date Received
    December 20, 2013
    Date of Event
    November 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K952913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE REMAINS UNDER INVESTIGATION. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE CUSTOMER. THIS REPORT IS BASED ON INFO RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS. BY SUBMITTING THIS REPORT THE COMPANY IS NOT ADMITTING THAT THE PRODUCT IDENTIFIED HAS MALFUNCTIONS, IS DEFECTIVE, OR HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. INFO PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFO CURRENTLY AVAILABLE IS TRUE AND ACCURATE. A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SINCE (B)(6) 2010, INAPPROPRIATE DOSES HAVE BEEN DELIVERED TO PATIENTS RECEIVING GYN INTRA-CAVITARY RADIATION THERAPY USING THE AL13122005-FLETCHER-SUIT DELCLOS STYLE APPLICATOR SET IN CONJUNCTION WITH THE AL13123000-FSD TYPE GYN COUPLING CATHETER SET. THE DISTANCE OF THE DISTAL END OF THE COLPOSTAT AND PROXIMAL END OF THE TRANSFER COUPLING TUBE HAD NOT BEEN MEASURED CORRECTLY WITH THE MEASUREMENT WIRE. THE RADIATION SOURCE WAS THEREFORE MISPLACED AND THE TARGET ORGANS WERE MISSED. THE NUMBER OF PTS AFFECTED IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669093 FLETCHER-SUITE DELCLOS STYLE APPLICATOR SET INTRACAVITARY BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other