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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Cancer (3262)

Event Date 07/23/2013

Event Type  Injury  

Event Description

A clinical research site reported that study pt (b)(6) received cyberknife treatment for prostate cancer on (b)(6) 2009.In (b)(6) 2013, the pt was diagnosed with a grade 3 papillary bladder tumor.

Manufacturer Narrative

Radiotherapy treatment for prostate cancer has an approximate five percent risk of contributing to subsequent bladder cancer.While it is not possible to make a definitive determination as to the root cause of the bladder cancer, the prior prostate radiosurgery treatment cannot be ruled out.(b)(4).

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Type of Device: CYBERKNIFE SYSTEM
• Manufacturer (Section D): ACCURAY, INC; sunnyvale CA
• Manufacturer Contact: laura walter ; 1310 orleans drive; sunnyvale, CA 94089 ; 6088243402
• MDR Report Key: 3853142
• MDR Text Key: 4658370
• Report Number: 2950679-2014-00002
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2014
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR
• Patient Weight: 88