MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Device Problems Computer Software Problem (1112); Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

Customer alleged that the tdc (treatment delivery console) froze before the setup scan was complete.The gantry panels then showed "radiating".Currently, there is no known injury to the patient.This issue is under investigation.

Event Description

The tdc (treatment delivery console) froze at the end of kvct and the gantry panels showed "radiating".

Manufacturer Narrative

"customer alleged that the tdc froze before the setup scan was complete.The gantry panels then showed "radiating".There are no known injuries.The investigation found that when the issue occurs, the scs appears to hang immediately after kv delivery completes.The couch continues to move into the bore until the user intervenes or the couch reaches the end stop.Possible causes include a deadlock or an unhandled exception that causes several threads to go down.In all instances, kv radiation stops at the expected time (before the issue arises).An anomaly was identified.Total risk is acceptable.The customer can clear the issue with a reboot.In conclusion, there have been no injuries.The system has been rebooted and no further actions are required.The issue is being tracked and fixed through the anomaly.".

• Brand Name: RADIXACT TREATMENT DELIVERY SYSTEM
• Type of Device: 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: 17074756
• MDR Text Key: 316758521
• Report Number: 3003873069-2023-00010
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00811376030009
• UDI-Public: 010081137603000911210105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161146
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• 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