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

Model Number H-0000-0003

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  malfunction  

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 Description

A complaint was recently received for a problem involving a flex pivot joint failure.

• Brand Name: TOMOTHERAPY HI-ART TREATMENT SYSTEM
• Type of Device: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• Manufacturer (Section G): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: matthew vandervoort ; 1310 chesapeake terrace; sunnyvale, CA 94089 ; 4087164666
• MDR Report Key: 6140277
• MDR Text Key: 61539808
• Report Number: 3003873069-2016-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: M6581043090
• UDI-Public: M6581043090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: H-0000-0003
• Device Catalogue Number: H-0000-0003
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2003
• 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