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

Model Number	G4
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A mounting nut on the synchrony boom arm was loose due to the fse not retightening the nut enough.Investigation is in-progress.
Event or Problem Description
The synchrony boom arm had unintended motion.No death or serious injury was reported.
Additional Manufacturer Narrative
The field service engineer (fse) went to service the system and found an issue that would not allow the completion of the service event.After the fse re-assembled the system it was discovered the boom arm screw as loose.The nut became loose because the fse did not tighten it enough when he worked on the device.The system has since been corrected and the loose hardware was re-tightened.No further action is required.

• 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: 15089213
• Report Number: 3003873069-2022-00012
• Device Sequence Number: 5101286
• Product Code: IYE
• UDI-Device Identifier: M6580325000
• UDI-Public: +M6580325000/16D20190227E
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: G4
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2019
• 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