MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPHY HI-ART TREATMENT SYSTEM; TOMOTHERAPY TREATMENT SYSTEM

Model Number H-0000-0003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Burn (1755)

Event Date 10/01/2013

Event Type  Injury  

Event Description

A complaint was recently submitted for an event (radiation burns) that occurred in (b)(6) 2013.Technical product investigation to date has indicated that the system performed as intended and no system malfunction had occurred.

• Brand Name: TOMOTHERAPHY HI-ART TREATMENT SYSTEM
• Type of Device: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale, CA 94089
• Manufacturer Contact: elizabeth osuna ; 1310 chesapeake terrace; sunnyvale, CA 94089 ; 4087164731
• MDR Report Key: 5936274
• MDR Text Key: 54199827
• Report Number: 3003873069-2016-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K112776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H-0000-0003
• Device Catalogue Number: H-0000-0003
• Device Lot Number: N/A
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR