MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE TREATMENT DELIVERY SYSTEM; MEDICAL LINEAR ACCELERATOR

Model Number	M6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A customer in italy has observed rectal toxicities.This is a known side effect of radiation treatment for prostate cancer.According to the site, this patient received grade 3 rectal toxicity with a rectal ulceration.A clinical assessment was performed within accuray and it was determined that the toxicity was grade 2.The grade 2 toxicity was determined to be a serious injury.There is no indication that the system malfunctioned.This event is still under investigation.
Event or Problem Description
Rectal toxicity due to prostate treatment.
Additional Manufacturer Narrative
A meeting organized with abmedica and the customer focused on reviewing cyberknife prostate cancer treatments.Key topics included ct simulation and fiducial placement, treatment planning strategies (with emphasis on dose distribution and margin selection), and delivery quality, including managing uncertainties and deviations.The team compared current practices with literature-backed recommendations to improve outcomes.The customer was provided with a detailed review of (b)(4) patients treated between 2020 and 2024, highlighting toxicity outcomes, planning techniques, and delivery metrics like rigid body error and spacing.Best practices were reinforced across all stages¿from fiducial placement to patient setup and treatment delivery¿to align clinical results with published cyberknife advantages.

• Brand Name: CYBERKNIFE TREATMENT DELIVERY SYSTEM
• Common Device Name: MEDICAL LINEAR ACCELERATOR
• 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: 22865305
• Report Number: 3003873069-2025-00001
• Device Sequence Number: 18476374
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611190530
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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
• Device Model Number: M6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2019
• 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