BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-BOARD IMAGER (OBI)

    MDR report key: 1631263 · Received March 11, 2010

    Report

    Report Number
    2916710-2009-00083
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    November 9, 2009
    Report Date
    November 11, 2009
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K042720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL REPORT, VARIAN'S MEDICAL ADVISOR WAS NOT ABLE TO RENDER A MEDICAL EVALUATION ON WHETHER THIS EVENT MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. VARIAN FIELD STAFF WORKED WITH THE USER TO REPRODUCE THE ISSUE AND THAT INVESTIGATION HAS CONCLUDED THAT THE INCIDENT WAS CAUSED BY USER ERROR - THE NEW DRR WAS FOR A PLAN AT A DIFFERENT ISOCENTER POSITION, AND ATTACHING THIS DRR TO THE PLAN CAUSED THE ISOCENTER SHIFT ERROR. VARIAN WILL FURTHER INVESTIGATE THE ISSUE TO DETERMINE IF THE CAUSE COULD BE MITIGATED BY A CHANGE IN PRODUCT DESIGN. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STAFF IDENTIFIED AN INCORRECT ISOCENTER SHIFT AFTER PROSTATE PT WAS TREATED FOR 13 OF 39 TREATMENT FRACTIONS. WHEN RE-VISITING THE CONE BEAM CT SCAN (CBCT), IT WAS DISCOVERED THAT A NEW RT LAT ISO-CHECK "DRR" (DIGITALLY RECONSTRUCTED RADIOGRAPH) HAD BEEN CREATED BETWEEN FRACTION 1 AND 2 TO SHOW THE PROSTHETIC HIP. THIS DRR WAS FOR A FIELD AT A DIFFERENT ISOCENTER, BUT WAS APPLIED TO THE ORIGINAL PLAN. THE RESULT WAS AN INCORRECT SHIFT OF THE PLAN 1 CM INFERIOR AND 1 CM ANTERIOR TO THE INTENDED LOCATION. THE TREATING ONCOLOGIST HAS INDICATED THAT DUE TO THIS ISSUE, THERE IS A POTENTIAL OF TREATMENT UNDER DOSE. HOWEVER, IT IS IMPOSSIBLE TO ASCERTAIN THE IMPACT OF POTENTIAL UNDER DOSE. THERE MAY BE A REDUCED PROBABILITY OF TUMOR CONTROL. NO ADDITIONAL PT DATA WAS PROVIDED IN THE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-BOARD IMAGER (OBI) MEDICAL PARTICAL CHARGED RAD. THERAPY IYE VARIAN MEDICAL SYSTEMS H08

    Patients

    Seq Age Sex Outcome Treatment
    1