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	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During patient alignment, the snap ring dropped from the standard treatment couch (stc).The couch top rolled to the hardware limit (17.8 degrees), which is beyond the acceptable limit of 5 degrees.The patient did not fall off the couch and no mistreatment occurred.There are no known injuries.
Event or Problem Description
The standard treatment couch snap ring dropped, causing the couch to roll during patient alignment.
Additional Manufacturer Narrative
The root cause was discovered during repair and is attributed to system wear.Since the linkage mechanism continued to support the patient until it completely disconnected, this change of position was sudden and significant.Until the point of disconnect, the linkage continued to function as intended.Any motion allowed by the linkage would be accounted for by the target locating subsystem and handled in the same manner as the patient making small motions.The mechanism failure occurred during the patient alignment phase and effectively rendered the system inoperable as the patient could no longer be aligned.Because of frequent patient tracking, there is no risk of mistreatment beyond what is normally accepted.The major risk of this event would be the patient falling from the table, but this did not occur.

• 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; 1240 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717 ; 6082842971
• MDR Report Key: 17710153
• Report Number: 3003873069-2023-00013
• Device Sequence Number: 20512481
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611220408
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 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: 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: 08/25/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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