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4 records match for Accuray
20221 registryClear
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Not graded by the source2022-10-22FDA MAUDE3003873069-2022-00018CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SIDE EFFECT - ANESTHESIA DELAROSA (AD).
cause not established3003873069-2022-00018AccurayRead the record ↗Not graded by the source2022-08-23FDA MAUDE3003873069-2022-00016CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT EXPERIENCED URINARY AND FECAL RETENTION AND INCONTINENCE AFTER CYBERKNIFE TREATMENTS.
cause not established3003873069-2022-00016AccurayRead the record ↗Not graded by the source2022-06-06FDA MAUDE3003873069-2022-00010CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A CUSTOMER CONTACTED ACCURAY INDICATING THERE WAS A POTENTIAL MISTREATMENT THAT OCCURRED AT THEIR SITE.
cause not established3003873069-2022-00010AccurayRead the record ↗Not graded by the source2022-02-15FDA MAUDE3003873069-2022-00009CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FEMALE PATIENT (CURRENTLY (B)(6)) RECEIVED CYBERKNIFE STEREOTACTIC RADIOSURGERY (SRS) IN 2018. ON (B)(6) 2022 DURING BRAIN SURGERY THE PATIENT WAS FOUND TO HAVE "RADIATION-RELATED NECROSIS WITH CAVERNOMA-LIKE VASCULAR PROLIFERATION AND VASCULAR INFLAMMATION".
cause not established3003873069-2022-00009AccurayRead the record ↗