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

Device Problem Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2014

Event Type  malfunction  

Event Description

It was reported that the robot had hit the ceiling while going to pick up the collimator during a treatment.There is no report of pt injury.

Manufacturer Narrative

This issue is currently under investigation.A follow up report will be filed when the investigation is complete.

• Brand Name: CYBERKNIFE 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 Key: 3790374
• MDR Text Key: 4443167
• Report Number: 2950679-2014-00001
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• 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 Received: 03/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• 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