MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM; CYBERKNIFE SYSTEM

Model Number G4

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Accuray incorporated evaluated the device in question and determined that a failure of two set screws led to a mechanical failure of the standard treatment couch table top.This unexpected couch table top descent occurred while the operator was removing a patient from the couch.It was determined that the two set screws were loose, having presumably backed out.The set screws hold the treatment couch table top roll axis pivot pin in place, with each end in a pivot mounting block.When the set screws backed out, the roll axis pivot pin slid partially out of one of the mounting blocks, removing partial support to the treatment couch table top, leading to the unexpected descent.There was no operator or patient injury.However, given the potential for injury this is being reported and a correction for this is being investigated.

Event Description

A complaint was recently received for a problem where the standard treatment couch experienced an unexpected descent due to a set screw torque issue while a patient was being removed.There was no injury.

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Type of Device: CYBERKNIFE SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• Manufacturer (Section G): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: matthew vandervoort ; 1310 chesapeake terrace; sunnyvale, CA 94089 ; 4067164666
• MDR Report Key: 6140279
• MDR Text Key: 61506197
• Report Number: 2950679-2016-00006
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G4
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1