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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCURAY, INC. CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM; CYBERKNIFE SYSTEM
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ACCURAY, INC. CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM; CYBERKNIFE SYSTEM Back to Search Results
Device Problem Unintended Collision (1429)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2014
Event Type  malfunction  
Event Description
The customer reported that the robot wrist made contact with the robot's upper arm during a pt treatment.There is no report of injury associated with this event.This is the first of two incidents reported within the same week at this site.
 
Manufacturer Narrative
Preliminary investigation has determined that the two objects in question, the robot wrist and robot upper arm, were not previously considered to be at risk of contacting each other, and the proximity detection program was not designed to actively monitor their relationship.This resulted in unintended contact between the two objects.(b)(4).
 
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Brand Name
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Type of Device
CYBERKNIFE SYSTEM
Manufacturer (Section D)
ACCURAY, INC.
sunnyvale CA
Manufacturer Contact
laura walter
1310 chesapeake terrace
sunnyvale, CA 94089
6088243402
MDR Report Key3917795
MDR Text Key4581756
Report Number2950679-2014-00004
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 Other Health Care Professional
Type of Report Initial
Report Date 05/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2009
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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