MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was inadvertently exposed to the treatment fraction for 5.2 seconds when imaging was intended.
Additional 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.
Additional 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.
Additional Manufacturer Narrative
Udi and date of manufacture correction: during a review it was discovered that the udi and date of manufacture was incorrectly typed into the service work order system.The information has now been corrected in the system and this report is being updated.See d4 and h4 of this report.

• Brand Name: RADIXACT TREATMENT DELIVERY SYSTEM
• Common Device Name: 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
• Report Number: 3003873069-2023-00018
• Device Sequence Number: 7352654
• Product Code: IYE
• UDI-Device Identifier: 00811376030009
• UDI-Public: 010081137603000911190311
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K223159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023; Not provided
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/09/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown