MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY SYS

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

Patient Problem Fistula (1862)

Event Date 11/05/2014

Event Type  Death  

Event Description

During review of a manuscript titled "feasibility and efficacy of helical tomotherapy imrt for stage ii non-small cell lung cancer: feasible and efficacy in comparison with conventionally fractionated via three-dimension conformal radiotherapy3d-crt----: a phase i/to ii clinical trial" an adverse event was noted.One pt with a paraesophageal tumor developed a fatal hemoptysis and died of an esophagotracheal fistula at 13th months after the start of radiotherapy.To date, there is no data to suggest this was due to a product malfunction.

Manufacturer Narrative

(b)(4).

• Brand Name: TOMOTHERAPY SYS
• Type of Device: TOMOTHERAPY
• Manufacturer (Section D): ACCURAY INCORPORATED; madison WI
• Manufacturer Contact: joy sacmar ; 1310 chesapeake terrace; sunnyvale, CA 94089 ; 4087164600
• MDR Report Key: 4307426
• MDR Text Key: 5273482
• Report Number: 3003873069-2014-00003
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death