CYBERKNIFE 054000-004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-04 for CYBERKNIFE 054000-004 manufactured by Accuray Incorporated.

MAUDE Entry Details

Report Number3003873069-2019-00012
MDR Report Key9273303
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-04
Date of Report2019-11-04
Date of Event2019-10-16
Date Mfgr Received2019-10-16
Date Added to Maude2019-11-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DANIEL BIANK
Manufacturer Street1240 DEMING WAY
Manufacturer CityMADISON WI 53717
Manufacturer CountryUS
Manufacturer Postal53717
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCYBERKNIFE
Generic NameCYBERKNIFE
Product CodeIYE
Date Received2019-11-04
Model Number054000-004
Catalog Number054000-004
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerACCURAY INCORPORATED
Manufacturer Address1240 DEMING WAY MADISON WI 53717 US 53717


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.