BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM FLETCHER-STYLE APPLICATOR SET

    MDR report key: 2852864 · Received November 27, 2012

    Report

    Report Number
    9612638-2012-00013
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 27, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K983436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP OF THE MDR IS EXPECTED AND WILL BE SUBMITTED AS SOON AS THE FINAL INVESTIGATION RESULT IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PROBLEM DURING A BRACHYTHERAPY GYNECOLOGICAL TREATMENT. FOR THE TREATMENT A TITANIUM FLETCHER-STYLE APPLICATOR (GM11006860 / 3 PROBES) WAS USED. DURING THE TREATMENT PLANNING PROCEDURE THE CUSTOMER OBSERVED AN INCORRECT ANGLE OF THE INTRAUTERINE PROBE (GM11006680) BUT CHANGING THE ANGLE BY STANDARD ADJUSTMENT PROCEDURE WAS NOT POSSIBLE. THE CUSTOMER DECIDED AT THIS STAGE TO REMOVE THE TAMPONADE, WHICH WAS USED TO IMMOBILIZE THE APPLICATOR AND FOUND THAT THE INTRAUTERINE PROBE WAS BROKEN INTO TWO PIECES. CUSTOMER REMOVED APPLICATOR FROM PATIENT. CUSTOMER REMOVED DISTAL PART OF THE PROBE (WHICH REMAINED INSIDE THE PATIENT) WITH FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM FLETCHER-STYLE APPLICATOR SET BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC. GM11006680 D21

    Patients

    Seq Age Sex Outcome Treatment
    1 Other