MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Radiation Burn (1755)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient indicated they experienced blistering and burning sensation after receiving radiation treatment on the radixact system during a speaking engagement.The patient was subsequently hospitalized for pain management.A clinical affairs assessment has determined the event to be a serious injury.
Event or Problem Description
Patient reported experiencing blistering and burning sensation after receiving radiation treatment on the radixact system.

• 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 ; 6088242971
• MDR Report Key: 18355713
• Report Number: 3003873069-2023-00019
• Device Sequence Number: 20481532
• Product Code: IYE
• UDI-Device Identifier: M65810600000
• UDI-Public: +M65810600000/16D201609014
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Race: White