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Not graded by the source2013-07-23FDA MAUDEAccuray2950679-2014-00002CyberKnife
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.
cause not established2950679-2014-00002AccurayRead the record ↗Not graded by the source2013-02-13FDA MAUDEAccuray2950679-2013-00004CyberKnife
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.
cause not established2950679-2013-00004AccurayRead the record ↗