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

Model Number	M6
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During go live for the system, the couch roll joint got loose and the circlip came out.The arm detached from the shaft and the circlip was missing.There was a total decoupling and therefore, the rotation was beyond 10 degrees.To correct the event, the fse (field service engineer) re-inserted the axis and installed a new circlip.There was no patient on the couch as the event occurred during a simulation.Investigation is ongoing.
Event or Problem Description
Standard treatment couch roll joint was loose and circlip came out causing the couch to rotate.
Additional Manufacturer Narrative
The root cause of the circlip coming off of the system is not known.However, the result of this event is that the couch rolled beyond 10 degrees.The risk rationale and benefit risk analysis is documented in the related risk assessment.The overall risk is vbra (verify benefit risk analysis).The circlip was replaced.

• 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: 19562294
• Report Number: 3003873069-2024-00004
• Device Sequence Number: 7574683
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611231130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170788
• 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: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: M6
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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