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

Model Number	S7
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The cyberknife imaging had shown a couch sag more than 10 degrees for a prostate patient.
Additional Manufacturer Narrative
The cyberknife imaging showed a couch sag of more than 10 degrees for a prostate patient.The couch/table was inspected and the investigation is on-going.
Additional Manufacturer Narrative
System functioning as expected.Issue can be attributed to user error with a patient positioned far too superior.

• 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: 16585590
• Report Number: 3003873069-2023-00004
• Device Sequence Number: 13878081
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611211012
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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: S7
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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