BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 2444139 · Received February 6, 2012

    Report

    Report Number
    2916710-2012-00002
    Event Type
    Other
    Date Received
    February 6, 2012
    Date of Event
    October 15, 2006
    Report Date
    January 13, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE IS UNK BECAUSE THE SPECIFIC DEVICE INVOLVED IN THE EVENT IS NOT KNOWN. THE DEVICE WAS NOT EVALUATED BY VARIAN, BECAUSE VARIAN WAS NOT ABLE TO OBTAIN THE NECESSARY INFO FROM THE FACILITY. VARIAN CONTACTED THE HOSPITAL, REQUESTING COMMENT ON THE PUBLISHED ARTICLE. (B)(4), PHYSICIST, STATED THAT HE WAS NOT INVOLVED WITH THIS EVENT, WHICH OCCURRED OVER 5 YEARS AGO, AND THAT HE DID NOT HAVE ANY OF THE DETAILS. MR. (B)(4) STATED THAT FULL INVESTIGATION OF THE MISTREATMENT WAS DONE AT THAT TIME AND THE RESULT HAS BEEN IMPROVED PROCESSES FROM THE LESSONS LEARNED. THE SITE ONLY HAS VARIAN CLINACS AND ONE OF THEM WAS USED FOR THE REPORTED EVENT AT THAT TIME. THE EQUIPMENT HAS SINCE BEEN UPGRADED TO NEW VARIAN CLINICS. MR. (B)(4) DECLINED TO PROVIDE ANY FURTHER INFO. NO FURTHER F/U TO THIS REPORT IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    ON 01/13/2012, VARIAN BECAME AWARE OF A FOX NEW ARTICLE POSTED ON THE FOX WEBSITE 01/11/2011: "CT DOCTOR INJECTED RADIATION INTO WRONG SPOT ON PT 29 TIMES." THE ARTICLE STATED THAT RECORDS SHOW THAT A PT WITH A RECURRENT MASS IN THE RIGHT SIDE OF THE MOUTH RECEIVED RADIATION DELIVERED TO THE LEFT SIDE OF THE MOUTH INSTEAD, IN (B)(6) 2006. THE ARTICLE FURTHER STATED THAT THE MISTAKE WAS DISCOVERED AFTER THE 29TH SESSION, AND A MAKE-UP PLAN WAS IMPLEMENTED. IN CONCLUSION, THE ARTICLE STATED THAT ANOTHER DOCTOR WHO RECEIVED THE CASE SAID THAT WHILE THE EXCESS TREATMENTS WERE A DEVIATION FROM THE STANDARD OF CARE, THE FINAL PLAN AND THE PT'S OUTCOME WERE FAIRLY SIMILAR TO WHAT COULD HAVE BEEN EXPECTED - THOUGH WITH A DIFFERENT DAILY DOSAGE OVER TIME. NO REPORT OF INJURY WAS RECEIVED BY VARIAN. DATE OF EVENT - ONLY THE MONTH WAS REPORTED IN THE NEWS ARTICLE; THE DATE (B)(6) 2006 IS APPROXIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1