BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEGMENTED CERVIX APPLICATOR SET

    MDR report key: 3116052 · Received May 9, 2013

    Report

    Report Number
    9612638-2013-00006
    Event Type
    Other
    Date Received
    May 9, 2013
    Report Date
    April 19, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K033371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ISSUE WAS IDENTIFIED REGARDING THE FLEXIBLE PROBE TO GUIDING TUBE CONNECTION POINT OF THE SEGMENTED CYCLINGER APPLICATOR SET, GM11004150 AND AN ISSUE ANALYSIS WAS CONDUCTED BY VARIAN MEDICAL SYSTEMS, INC. THE RESULT WAS A DETERMINATION THAT THE SET SHOULD NOT BE USED FOR PDR TREATMENTS. THE SEGMENTED CERVIX APPLICATOR SET, GM11004540 WAS DETERMINED TO HAVE THE EXACT SAME ISSUE WHICH WAS DETAILED IN A DEVICE APPLICABILITY ASSESSMENT; THEREFORE, THE RECALL IS EXTENDED TO THIS APPLICATOR SET AS WELL (REFERENCE #9612638-05/03/13-0002R). THERE HAVE BEEN NO CUSTOMERS AFFECTED IN THE UNITED STATES BY THIS ISSUE. ADDITIONALLY, THERE HAVE NOT BEEN ANY REPORTED INCIDENTS REGARDING THIS ISSUE FROM USERS OF THE SEGMENTED CERVIX APPLICATOR SET, GM11004540. NO FURTHER FOLLOW UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE SEGMENTED CERVIX APPLICATOR SET, GM11004540, IS USED BY SECURING THE FLEXIBLE PROBE TO THE GUIDING TUBE BY A CLAMPING NUT (CLAMPING NUT FOR GUIDING TUBE GM11008560.) THE FLEXIBLE PROBE CAN SLIP IN THE GUIDE TUBE UNDER SUFFICIENT FORCE WHEN CORRECTLY ATTACHED TO THE GUIDE TUBE, WITH THE APPLICATOR SECURED IN THE PATIENT'S BODY. PATIENT MOVEMENT DURING TREATMENT OR BETWEEN PULSES CAN RESULT IN SIGNIFICANT FORCE APPLIED TO THE FLEXIBLE PROBE, WHEN THE SEGMENTED CERVIX APPLICATOR IS SECURED IN THE PATIENT. THIS MAY NOT BE DETECTED IMMEDIATELY DURING PDR BRACHYTHERAPY DUE TO THE LONG TOTAL TREATMENT TIME (24-48 HOURS) WITHOUT CONSTANT PATIENT MONITORING. DURING TREATMENT, IF THE FLEXIBLE PROBE IS SUBJECTED TO SUFFICIENT FORCE TO CAUSE IT TO SLIP AT THE CLAMPING NUT, DWELL POSITIONS MAY BE DELIVERED OUTSIDE THE TARGET REGION AND IN THE PROXIMITY OF CRITICAL STRUCTURES. DUE TO THE FACT THAT PATIENT MOVEMENTS DURING PDR BRACHYTHERAPY MAY NOT BE DETECTED UNTIL AFTER A SERIES OF PULSES HAVE BEEN DELIVERED, AND GIVEN THE COMMON USE OF FLEXIBLE FIXATION IN TREATMENT SESSIONS, VARIAN MEDICAL SYSTEMS IS REMOVING THE SEGMENTED CERVIX APPLICATOR SET FOR USE WITH PDR BRACHYTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204272 SEGMENTED CERVIX APPLICATOR SET INTRACAVITARY BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC. FOR PDR TREATMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other