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

Device Problem Protective Measures Problem (3015)

Patient Problem Electric Shock (2554)

Event Date 07/24/2014

Event Type  Injury  

Event Description

It was reported by an accuracy employee, that a field service engineer received an electrical shock while servicing the system modulator cabinet at the point of the circuit breaker three.The field service engineer reported burns on his fingers at the point of entry, along with heart palpitations and an "unusual reaction of the nervous system." there is no report of serious injury or death.

Manufacturer Narrative

Investigation has determined that the field engineer neglected to discharge the capacitor after re-powering on the system.In addition, it was reported that there is no service documentation for this procedure.A capa has been opened to address this issue.There is no report of system malfunction associated with this event.(b)(4).

• 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: 4071646
• MDR Text Key: 4900207
• Report Number: 2950679-2014-00008
• 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: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2010
• 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