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Not graded by the source2007-07-01FDA MAUDE2950679-2013-00006CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 04/11/2013 WHILE READING A DRAFT RESEARCH PAPER ENTITLED "STEREOTACTIC BODY RADIATION THERAPY FOR HEPATOCELLULAR CARCINOMA; PROGNOSTIC FACTORS OF LOCAL CONTROL, OVERALL SURVIVAL, AND TOXICITY"; AN ACCURAY EMPLOYEE BECAME AWARE OF AN ADVERSE EVENT. THIS STUDY IS PARTIALLY FUNDED BY ACCURAY. THE PAPER REPORTS THAT THREE MONTHS AFTER A CYBERKNIFE TREATMENT FOR A TUMOR IN THE LIVER, ONE PATIENT EXPERIENCED A GRADE 4 GASTRIC ULCER, RESULTING IN A DIGESTIVE HEMORRHAGE, WHICH WAS TREATED. THE PAPER REPORTS FOLLOWING THE ADVERSE OUTCOME "TREATMENT PLANS WERE REVIEWED AND STRICT CONSTRAINTS WERE DEFINED FOR SUBSEQUENT TREATMENTS." THE PRINCIPLE INVESTIGATOR CONFIRMED THE CYBERKNIFE DID NOT MALFUNCTION.
cause not established2950679-2013-00006AccurayRead the record ↗