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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM; MEDICAL LINEAR ACCELERATOR
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ACCURAY INCORPORATED CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM; MEDICAL LINEAR ACCELERATOR Back to Search Results
Model Number VSI
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2020
Event Type  malfunction  
Event Description
The cyberknife system boom arm and camera attached to the synchrony camera extension mount fell due to the threading at the end of the extension mount breaking.
 
Manufacturer Narrative
The investigation concluded that the work instruction for the synchrony camera assembly attachment to the extension mount was not followed.A rivet installed to hold up the synchrony camera and the boom arm was installed in an incorrect location on the extension mount threading.This incorrect placement caused the threading to break and the assembly to fall.The initial synchrony camera assembly installation was performed by a distributor, who is no longer with the company.An event report has been opened to track correction of the broken part.
 
Event Description
The cyberknife system boom arm and camera attached to the synchrony camera extension mount fell due to the threading at the end of the extension mount breaking.
 
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Brand Name
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Type of Device
MEDICAL LINEAR ACCELERATOR
Manufacturer (Section D)
ACCURAY INCORPORATED
1209 deming way
madison WI 53717
MDR Report Key10488062
MDR Text Key207752632
Report Number3003873069-2020-00001
Device Sequence Number1
Product Code IYE
Combination Product (y/n)N
PMA/PMN Number
K122137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVSI
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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