MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are allegations that the patient's scan position was different from the treatment position.The issue is currently under investigation.
Event or Problem Description
There was an allegation that a patient's scan position was different from their treatment position.
Additional Manufacturer Narrative
The investigation determined that the event only caused additional imaging dose to the patient.This is not considered a serious injury, therefore, this event was determined to be not reportable.

• Brand Name: RADIXACT TREATMENT DELIVERY SYSTEM
• Common Device Name: RADIXACT
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer (Section G): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1209 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 18975247
• Report Number: 3003873069-2024-00002
• Device Sequence Number: 6694181
• Product Code: IYE
• UDI-Device Identifier: 00811376030009
• UDI-Public: 010081137603000911220324
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/12/2024

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: Not provided
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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