BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLETCHER-SUIT-DELCOS-STYLE APPLICATOR SET

    MDR report key: 3621486 · Received January 31, 2014

    Report

    Report Number
    9612638-2014-00001
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 3, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K120731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SHARP EDGES WERE FOUND THROUGH THE VISUAL AND HAPTIC INSPECTION OF THE RETURNED AL07344000 TITANIUM CERVICAL STOP. TWO CERVICAL STOPPERS FROM STOCK, MANUFACTURED IN 2009, WERE INSPECTED AND NO SHARP EDGES WERE NOTICED. THIS SUGGESTS THAT THE CURRENT ISSUE, REPORTED IN VARIAN COMPLAINT (B)(4), IS NOT RELATED TO A CHANGE IN THE MANUFACTURING PROCESSES. THE RELATED DRAWINGS OF THE SUSPECT PART WERE REVIEWED. FROM A DESIGN STANDPOINT, THE TITANIUM CERVICAL STOP DOES NOT INDICATE THAT THERE IS A RISK OF SCRATCHING A PATIENT TO BLEEDING. THE SET SCREW HAS A LENGTH THAT ENSURES THAT IT IS NOT PROTRUDING OUT OF THE CERVIX MARKER IF TIGHTENED CORRECTLY TO THE TANDEM. THE CUSTOMER'S ALLEGATION WAS NOT ABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE DID NOT MALFUNCTION. NO FURTHER F/U TO THIS REPORT IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY TREATED A PATIENT USING THE AL13030001-FLETCHER-SUIT-DELCOS-STYLE APPLICATOR WITH THE AL07344000-TITANIUM CERVICAL STOP. THE CUSTOMER STATED THAT THIS PATIENT EXPERIENCED AN ULCERATION AT THE LOCATION OF THE CERVICAL STOP. THIS IS THE THIRD INCIDENT REPORTED. DETAILS ON OTHER 2 INCIDENTS FILED UNDER MFR REPORT #9612638-2013-00012 AND 9612638-2013-00013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68589 FLETCHER-SUIT-DELCOS-STYLE APPLICATOR SET INTRACAVITARY BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other