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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCURAY, INCORPORATED CYBERINFE ROBOTIC RADIOSURGERY SYSTEM; CYBERKNIFE SYSTEM
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ACCURAY, INCORPORATED CYBERINFE ROBOTIC RADIOSURGERY SYSTEM; CYBERKNIFE SYSTEM Back to Search Results
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Reaction (2414)
Event Date 06/11/2014
Event Type  Injury  
Event Description
The customer reported that a pt being treated for dcis (ductal carcinoma in situ) on the cyberknife partial breast phrase i clinical trial at 3750 cgy/5 fractions, developed what was thought to be cellulitis, followed by marked edema and breast fibrosis.
 
Manufacturer Narrative
The customer reports that there was no malfunction of the device.However, the reported condition of the pt is an unexpected outcome.The customer also reports that the pt is currently under medical management with several treatment options.#(b)(4).
 
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Brand Name
CYBERINFE ROBOTIC RADIOSURGERY SYSTEM
Type of Device
CYBERKNIFE SYSTEM
Manufacturer (Section D)
ACCURAY, INCORPORATED
sunnyvale CA
Manufacturer Contact
laura walter
1310 chesapeake terrace
sunnyvale, CA 94089
6088243402
MDR Report Key3955102
MDR Text Key4627878
Report Number2950679-2014-00006
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 06/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/11/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/21/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
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