BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICAL GUIDANCE PLATFORM

    MDR report key: 2455443 · Received February 10, 2012

    Report

    Report Number
    2916710-2012-00003
    Event Type
    Injury
    Date Received
    February 10, 2012
    Report Date
    January 27, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K071360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CLASSIFIED THE FAILURE AS A DESIGN DEFICIENCY - WHEN THE USER IS 'DISCARDING' THE OUTLIER SLICE, AN AVERAGE STACK TILT ANGLE IS CALCULATED, WHICH SUBSEQUENTLY IS APPLIED IN THE STEREOTACTIC VOLUME CREATION. IF THIS ISSUE GOES UNDETECTED, THE REPORTED COORDINATES OF THE ISOCENTER WILL BE INCORRECT AND A MISTREATMENT COULD RESULT. A PRODUCT NOTIFICATION LETTER WILL BE SENT TO AFFECTED CUSTOMERS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADDITIONAL INFO REGARDING PT STATUS WAS REPORTED. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LOCALIZATION ERROR IN FASTPLAN THAT LED TO A PARTIAL MISS OF THE TARGET AND IRRADIATION OF UNINTENDED VOLUME. FOLLOWING INVESTIGATION OF A PREVIOUS REPORTED COMPLAINT ((B)(4)), THE CUSTOMER REVIEW PT DATA AND DISCOVERED THAT A PT HAD AN INCORRECT LOCALIZATION DUE TO THE DISCARD OPTION BEING SELECTED IN THE FASTPLAN LOCALIZATION. THE PT RECEIVED AN SRS TREATMENT WITH THE INCORRECT LOCALIZATION. DOSE INFO IS SUPPLIED BELOW. PLANNED TREATMENT: T1: 2100CGY TO 100% (0.27CC) OF TUMOR VOLUME. T2: 2100CGY TO 100% (0.37CC) OF TUMOR VOLUME 0 MU 1 CGY. ACTUAL TREATMENT: T1: 2100CGY TO 84% OF TUMOR VOLUME 1800CGY TO 100% OF TUMOR VOLUME. T2: 2100CGY TO 54% (0.20CC) OF TUMOR VOLUME. A 1400CGY TO 100% OF TUMOR VOLUME. (NOTE THESE VOLUMES WERE RECONTOURED BY THE PHYSICIAN, BUT ARE SIMILAR TO THE ORIGINAL VOLUME). DOSE DELIVERED TO THE TARGETED TUMOR, EXCEED THE TOTAL PLANNED DOSE: T1: 14.3%, T2: 33.3%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL GUIDANCE PLATFORM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS HZ3

    Patients

    Seq Age Sex Outcome Treatment
    1