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

Model Number	H-0000-0003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was recently received for a problem involving a flex pivot joint failure.The primary collimation system is comprised of two jaws that control the width (thickness) of the radiation beam.The two halves of the jaw are opened and closed with electric actuators.These actuators are held on mounting brackets by flex pivots which allow rotation while providing a tight fit.In this case, the flex pivot joints cracked (likely due to a torque issue), and the width of the radiation beam was not appropriately collimated resulting in under-dose by 2-11%.Subsequent compensating fractions were delivered according to a physician approved treatment plan.We were informed that the customer/user submitted a medwatch report.
Event or Problem Description
A complaint was recently received for a problem involving a flex pivot joint failure.

• Brand Name: TOMOTHERAPY HI-ART TREATMENT SYSTEM
• Common Device Name: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• MDR Report Key: 6140277
• Report Number: 3003873069-2016-00002
• Device Sequence Number: 509924
• Product Code: IYE
• UDI-Device Identifier: M6581043090
• UDI-Public: M6581043090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H-0000-0003
• Device Catalogue Number: H-0000-0003
• Device Lot Number: N/A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1