MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2023

Event Type  Injury  

Event Description

The patient was inadvertently exposed to the treatment fraction for 5.2 seconds when imaging was intended.

Manufacturer Narrative

The treatment tab was opened before the mvct (mega volt computed tomography) was acquired.The user thought he was viewing the scan screen, so with the treat screen displayed, he turned the key to image and then pressed the start button on the status console.The patient was exposed to the treatment fraction for 5.2 seconds when imaging was intended.It is not yet known at this time if there wa a serious injury to the patient.Please note, this report was initially submitted under manufacturer number 3003893069-2023-00018 on 2023-dec-15.

Manufacturer Narrative

An analysis was completed of the dose deviation that the patient received.The result of that analysis indicated some deviations in the intended dose for delivery in the specific fraction, but negligible deviation from the intended prescription dose, both to the target and to the oars (organs at risk).The incident was assessed as user error, particularly because the user continued on the treat panel even though they were intending to scan the patient for positioning.The overall risk was acceptable and there was no serious injury to the patient.

• Brand Name: RADIXACT TREATMENT DELIVERY SYSTEM
• Type of Device: RADIXACT
• Manufacturer (Section D): ACCURAY INCORPORATED; 1240 deming way; madison WI 53717
• Manufacturer (Section G): ACCURAY INCORPORATED; 1240 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717
• MDR Report Key: 18677907
• MDR Text Key: 335074616
• Report Number: 3003873069-2023-00018
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K223159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2020
• 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