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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCURAY, INC CYBERKNIFE; SYSTEM, RADIATION THERAPY, SOFTWARE
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ACCURAY, INC CYBERKNIFE; SYSTEM, RADIATION THERAPY, SOFTWARE Back to Search Results
Device Problem Programming Issue (3014)
Patient Problem No Information (3190)
Event Date 01/14/2015
Event Type  malfunction  
Event Description
During a lung simulation on the cyberknife, it was noted that the simulation software yielded an unexpected result for the tumor tracking method.The cyberknife software indicated that the tumor tracking method should be a "1-view a" instead of the most logical choice of "1-view b".The result contradicted the visual analysis by the therapists, the md and two physicists who were observing the procedure.After contacting the vendor, accuray inc., it was learned that this was a known software bug for version 9.6 on the cyberknife console software.The software had been installed in 2012 and the anomaly had not been encountered up to this time.No mention of this software anomaly is mentioned in the version 9.6 release notes.The vendor also stated that no corrective action bulletins had been issued regarding the anomaly.
 
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Brand Name
CYBERKNIFE
Type of Device
SYSTEM, RADIATION THERAPY, SOFTWARE
Manufacturer (Section D)
ACCURAY, INC
1310 chesapeake terrace
sunnyvale CA 94089
MDR Report Key4444924
MDR Text Key16084570
Report Number4444924
Device Sequence Number1
Product Code IYE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/20/2015
Device Age3 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/23/2015
Patient Sequence Number1
Patient Age81 YR
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