BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAGINAL CYLINDER APPLICATOR

    MDR report key: 2612722 · Received June 1, 2012

    Report

    Report Number
    9612638-2012-00008
    Event Type
    Other
    Date Received
    June 1, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 8, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K952913
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    USER DID NOT FOLLOW INSTRUCTIONS FOR USE. NO FURTHER FOLLOW UP OF THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEY USED A VAGINAL CYLINDER (AL07028008) IN COMBINATION WITH A SOURCE GUIDE TUBE (AL07292001) FOR A BRACYTHERAPY TREATMENT ON (B)(6) 2012. PRIOR TO THE TREATMENT IT WAS NOT RECOGNIZED BY THE USER THAT THE COLLAR ON THE SOURCE GUIDE TUBE WAS MOVEABLE, WHICH LED TO AN INCORRECT POSITIONING OF THE SOURCE GUIDE TUBE IN THE CYLINDER. THE TREATMENT WAS PERFORMED WITH AN INCORRECT SET UP AND RESULTED IN AN MISS-POSITIONED RADIATION SOURCE. THE CYLINDER IS PART OF APPLICATOR SET AL13127000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAGINAL CYLINDER APPLICATOR BRACYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other