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Not graded by the source2012-06-11FDA MAUDE2950679-2012-00001CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPLICATIONS WERE DESCRIBED IN A ORAL PRESENTATION (B)(6). ACCURAY PREVIOUSLY CONTACTED THE PHYSICIAN AND CONFIRMED THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYS. THE PTS HAD RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYS IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. DUE TO THE NATURE AND EXTENT OF DISEASE, CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THE PTS IN THE STUDY. THE TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.
cause not established2950679-2012-00001AccurayRead the record ↗