MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE SYSTEM

Model Number G4

Device Problems Mechanical Problem (1384); Unintended Collision (1429)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

It was found that the issue could occur by manually moving the robot using "teach pendant" when an error has already occurred in the device.During the execution of "plan qa", no patient was on the treatment table, only a phantom was placed.We provided the manuals to the hospital that have the following description: "warning: maintain at least a 3 ft (1 m) distance from the treatment robot when operating the treatment robot manually.When moving the treatment robot, focus on the treatment robot rather than looking at the teach pendant to avoid collision.Collision with the treatment robot can result in serious injury or death of the user or patient." the operator in the treatment room remotely executed the manual return of the robot to the standby position using "teach pendant", and no health damage caused by this issue.Detailed investigation of the robot was conducted after the occurrence of the issue, but no mechanical abnormality was found.Therefore, we sent the parts of the robot (communication control device between the robot and the controller) to the robot supplier to investigate the root cause.Supplier is currently investigating the issue.

Event Description

It was reported that during the execution of "plan qa", a system error occurred and the operation of the manipulator arm (robot) was restricted.The operator who was operating outside the treatment room entered the room and used the "teach pendant" to manually return the robot to the standby position.Then, the robot descended and the vicinity of the tip of the head of the robot contacted the fixed collimator on the xchange collimator stand.

• Brand Name: CYBERKNIFE SYSTEM
• Type of Device: CYBERKNIFE
• Manufacturer (Section D): ACCURAY INCORPORATED; 1240 deming way; madison WI 53717
• Manufacturer Contact: adam st. sauver ; 1240 deming way; madison, WI 53717 ; 6088243417
• MDR Report Key: 7587606
• MDR Text Key: 111151578
• Report Number: 3003873069-2018-00002
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K091999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2018
• 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