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

Model Number	M6
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that a transformer within the x-ray generator of cyberknife treatment delivery system caught fire during installation.
Additional Manufacturer Narrative
Generator will be fully investigated to determine if further action is needed.
Additional Manufacturer Narrative
During system installation, the generator was not powering on correctly.The field service engineer (fse) replaced two boards within the generator as part of troubleshooting.After the replacements, the generator would not power on fully.Other connections were checked but no issue was observed.The generator was powered on once more and the transformer caught on fire.The fse extinguished the fire.Smoke was observed in the room but did not set off fire alarms.The room the generator is in, is separate from the patient treatment room.The fire did not spread beyond the transformer.No injury was reported.The generator was replaced.The original generator was shipped to accuray for inspection and then returned to the supplier for further investigation.Internal investigation revealed a misregistered connector on the control drac pcb, and a cracked power resistor on the input of the transformer in question.Final conclusion is the root cause of the fire was believed to be related to the power resistor failure.Supplier has confirmed this was a unique incident and no generators in production were identified to have a similar issue.No further action is needed.

• 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 ; 1240 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 12711568
• Report Number: 3003873069-2021-00004
• Device Sequence Number: 4957470
• Product Code: IYE
• UDI-Device Identifier: 00811376030016
• UDI-Public: 010081137603001611210909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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