MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY

Model Number 1018286

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

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

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

A field service engineer was replacing a fan filter during a preventative maintenance on the device.The power distribution unit was still powered on and the fans were still spinning when the fse tried to remove the filter.He had to do this with both hands and he touched the metal blades of the rotating fan with two fingers.One was slightly scratched and the other was fractured and needed surgery.It was determined that the work instruction indicating that the system should be powered off to prevent the fan from moving was not followed.

Event Description

A field service engineer's left hand fingers were caught by rotating fan blades while servicing the tomotherapy system.The injury resulted in cuts and fractures to the fingers; surgery was required to repair the fingers.

• Brand Name: TOMOTHERAPY
• Type of Device: TOMOTHERAPY
• Manufacturer (Section D): ACCURAY INCORPORATED; 1240 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717
• MDR Report Key: 8636246
• MDR Text Key: 145936319
• Report Number: 3003873069-2019-00007
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K082005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1018286
• Device Catalogue Number: 1018286
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization