MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT

Model Number 1060000

Device Problem Device Handling Problem (3265)

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

Event Date 07/28/2019

Event Type  malfunction  

Manufacturer Narrative

A 3rd party engineer was hit by the ssm.He went to the hospital and it was found that his leg was bruised.There were no bone irregularities and he was instructed to rest and that he would be able to walk on his own in four days.The trolley was set up in accordance to service instructions and the engineer assembled the trolley according to the instructions.The final step in this set-up is to insert the cotter pin into the trolley rod.There are cases where, due to the position of the cotter pin hole, washers must be removed and the trolley must be adjusted so that the trolley width and the rail width match.The service manager on site instructed the engineer to check and adjust the width of the trolley.The width was incorrect and this resulted in the fall of the ssm.There was no step in the instructions to verify the width of the trolley.This is being rectified in the installation instructions.

Event Description

During the installation of a radixact system, the trolley came off of the jib crane and the ssm (solid state modulator) dropped.There was no serious injury.

• Brand Name: RADIXACT
• Type of Device: RADIXACT
• Manufacturer (Section D): ACCURAY INCORPORATED; 1240 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717
• MDR Report Key: 8932019
• MDR Text Key: 205696866
• Report Number: 3003873069-2019-00009
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1060000
• Device Catalogue Number: 1060000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1