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

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Type  No Answer Provided  

Event Description

A potential adverse event was described in a clinical case report titled delayed esophageal perforation from stereotactic body radiation therapy (sbrt) for locally recurrent central non small cell lung cancer.This potential ae is under investigation to confirm whether the device caused or contributed to the event.

Manufacturer Narrative

Still under investigation.Follow-up report to be submitted.

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Type of Device: CYBERKNIFE SYSTEM
• Manufacturer (Section D): ACCURAY, INC.; sunnyvale CA
• Manufacturer Contact: coleen coleman ; 1310 chesapeake terrace; sunnyvale, CA 94089 ; 4087894446
• MDR Report Key: 4222985
• MDR Text Key: 20298796
• Report Number: 2950679-2014-00009
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1