MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Model Number	1060000
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently being investigated.
Event or Problem Description
A field service engineer in japan suffered a broken finger when using the gantry-mounted crane/hoist.The field service engineer tried to lift the jib crane and his hand got caught between the gantry and the jib, causing the injury.
Additional Manufacturer Narrative
During replacement of the linac, when the field service engineer (fse) tried to lift the jib crane to secure the space for the crane movement with standing on the gantry, he slipped his hand and his finger got caught between the gantry and the jib, causing the injury.Right hand middle finger was broken.During the linac replacement, a trained service personnel is required to lift the tomo-mounted jib crane to move it into position.The crane is located on the top of the gantry, which requires the trained service personnel to stand on the gantry frame or a ladder to maneuver it, which leaves them in an awkward posture.This overall process and job training was reviewed with the training team.In conclusion, it was determined the work instructions are adequate to perform this task and any risk is reduced as far as possible.Service personnel are trained on proper use of work instructions, which include appropriate ehs practices.No further action is required.

• Brand Name: RADIXACT TREATMENT DELIVERY SYSTEM
• Common Device Name: RADIXACT
• 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
• MDR Report Key: 14626006
• Report Number: 3003873069-2022-00008
• Device Sequence Number: 19739274
• Product Code: IYE
• UDI-Device Identifier: 00811376030009
• UDI-Public: (01)00811376030009(11)180430
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1060000
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2022
• Supplement Date Received by Manufacturer: 05/08/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Male