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

Model Number 28000

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

It was determined based on the characteristics of the malfunction that the most likely cause is a fatigue failure to the fold points.

Event Description

It was reported that the conditioning signal box (gun box) fell from the robot arm onto linac head.There was no pt user injury.

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Type of Device: CYBERKNIFE SYSTEM
• Manufacturer (Section D): ACCURAY, INC.; 1310 orleans drive; sunnyvale CA 94089
• Manufacturer (Section G): ACCURAY, INC.; 1209 deming way; madison WI 53717
• Manufacturer Contact: coleen coleman ; 1310 orleans drive; sunnyvale, CA 94089 ; 4087894446
• MDR Report Key: 5332324
• MDR Text Key: 34742903
• Report Number: 2950679-2015-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 28000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2015
• Was Device Evaluated by Manufacturer?: No
• 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