CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A CLINICAL RESEARCH SITE REPORTED THAT STUDY PT (B)(6) RECEIVED CYBERKNIFE TREATMENT FOR PROSTATE CANCER ON (B)(6) 2009. IN (B)(6) 2013, THE PT WAS DIAGNOSED WITH A GRADE 3 PAPILLARY BLADDER TUMOR.

CyberKnife — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A REVIEW OF A DRAFT CLINICAL PUBLICATION, AN ACCURAY EMPLOYEE NOTICED AN ADVERSE EVENT DESCRIBED. THE PUBLICATION DESCRIBES A STUDY OF 26 PTS TREATED FROM 2007-2011. THE PTS WERE CONSIDERED INOPERABLE PTS WITH LOCALIZED LUNG TUMORS. ON PT, WHO WAS PRESENTED WITH STEROID-REFRACTORY RADIATION PNEUMONITIS AT EIGHT MONTHS POST-TREATMENT, DIED OF ACUTE RESPIRATORY FAILURE FOUR MONTHS LATER. THE PT HAD UNDERGONE A LEFT PNEUMONECTOMY PRIOR TO RECEIVING RADIATION TREATMENT. THE COMPLICATION IS A KNOWN RISK OF TREATING A TUMOR WITHIN THE GIVEN TREATMENT PARAMETERS AND TUMOR LOCATION. THE PHYSICIAN INDICATED THAT THE PLANNED TREATMENT WAS DELIVERED AS INTENDED AND THAT THE AE WAS NOT DUE TO A MALFUNCTION OF THE DEVICE.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PT ENROLLED IN A NON ACCURACY SPONSORED STUDY, UNDER (B)(4) OVERSIGHT, EXPERIENCED COMPLICATIONS. THE PT EXPERIENCED PELVIC PAIN AND PROSTATE SLOUGHING AND UNDERWENT A CYSTOPROSTATECTOMY. THE PHYSICIAN INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE. DUE TO THE NATURE OF THE FOLLOW UP INTERVENTION, AND THE LACK OF RELATED DETAILS, THIS IS BEING REPORTED.