MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM; MEDICAL LINEAR ACCELERATOR

Model Number	M6
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fca collimator found dropped inside the plastic covers due to the screws holding it being not present.Issue is still under investigation.
Event or Problem Description
Customer had a failed aqa (automatic quality assurance).Fse (field service engineer) found the fca (fixed collimator assembly) had dropped inside the covers.
Additional Manufacturer Narrative
Customer reported the system failed laser alignment in the morning and had concerns on the failure impact to any previously treated patients.The fse removed the covers of the system and found that the fixed collimator assembly (fca) had detached.No injury occurred.Fse reattached the fca.The system was logs were reviewed.On the previous day, only two fractions were delivered to patients using the fca.After these two, mlc treatments were delivered, which require an xchange operation.The last two treatments of the day were fca head paths with fiducial tracking.These were phantom deliveries.It is most likely that the damage to the fixed collimator occurred during the xchange operation associated with changing from mlc to fixed collimator housings, so it is relatively unlikely that patients were harmed due to this mechanical failure.In conclusion, the event indicated that it was unlikely that a patient was harmed as the xchange operations that likely triggered this event occurred before qa deliveries and the problem was discovered before patients were treated the following day.

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY 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: 15089280
• Report Number: 3003873069-2022-00014
• Device Sequence Number: 17418557
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611190409
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 09/29/2022

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: 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: 07/07/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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