BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLETCHER-SUIT-DELCLOS-STYLE APPLICATOR SET

    MDR report key: 3627993 · Received February 7, 2014

    Report

    Report Number
    8020711-2014-00001
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    January 1, 2011
    Report Date
    January 9, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K120731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN BRACHYTHERAPY PERSONNEL CONDUCTED AN ON-SITE INVESTIGATION AT THE CUSTOMER'S FACILITY. THE TREATMENT WORKFLOW, SOURCE POSITIONING, AND APPLICATORS WERE ALL DISCUSSED AND EVALUATED. ALL SOURCE POSITIONING WAS ACCURATE AND DELIVERED WITHIN THE AFTERLOADER AS SPECIFIED. FROM THE GATHERED DATA, IT CAN BE CONCLUDED THAT ALL OF THE EQUIPMENT BEING USED AT THE HOSPITAL IS WITHIN SPECIFICATIONS AND OPERATING AS EXPECTED. THE ON-SITE VISIT IDENTIFIED POSSIBLE TREATMENT WORKFLOW CONTRIBUTING FACTORS BUT NO CONCLUSIONS COULD BE VERIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A GYN PATIENT HAS ALLEGEDLY SUFFERED SEVERE RADIATION REACTIONS OUTSIDE THE TREATMENT AREA. THE PATIENT WAS TREATED WITH THE AL13030000-FLETCHER-SUIT-DELCLOS-STYLE APPLICATOR SET (FSD) IN CONJUNCTION WITH THE (B)(4) REUSABLE TRANSFER GUIDE TUBES (RTGT). THEY STATED THAT THEY CHECKED THE PLANS AND DELIVERY, BUT "DIDN'T FIND ANY PROBLEM". THE CUSTOMER STATED THAT THE RTGTS ARE IN GOOD CONDITION AND ALL MEASURE WITHIN 1MM OF THE NOMINAL LENGTH OF 121.4 CM (120.0 CM FOR TREATMENT PLANNING). THERE IS A MARK ON THE RTGT, CORRELATING TO THE TABLE IN THE RTGT'S INSTRUCTIONS FOR USE, THAT IS USED TO VERIFY THE INSERTION DEPTH OF THE RTGT IN THE APPLICATOR. THIS IS CHECKED PRIOR TO AND AFTER TREATMENT BY 3 PEOPLE (PHYSICIAN, NURSE AND PHYSICIST). IN ADDITION, THE CUSTOMER INDICATED THAT THERE WAS NO EVIDENCE THAT THE APPLICATORS HAD BEEN PUSHED OUT OF THE PATIENT AT ANY POINT DURING THE TREATMENT. THE PATIENT WAS TREATED WITH 3 FRACTIONS OF 8GY EACH. THE PHYSICIAN HAS CONCLUDED THAT THE SUSPECTED TREATMENT ERROR OCCURRED FOR ONLY ON FRACTION, BECAUSE THE PATIENT HAD A FULL RESPONSE TO THE RADIATION, AND AT THIS TIME HE ASSUMES THERE WAS SUFFICIENT TARGET DOSE TO RESULT IN DISEASE RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80764 FLETCHER-SUIT-DELCLOS-STYLE APPLICATOR SET INTRACAVITARY BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other