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

Model Number	H-SERIES
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The fse (field service engineer) was performing a replacement of the union.When the union was put in the cart by using the boom crane, the boom crane lost balance of the union and it fell down.The fse's right hand was injured (laceration and finger fracture, bleeding and swelling) by the falling boom crane.
Event or Problem Description
The field service engineer's right hand was injured (laceration and finger fracture, bleeding and swelling) by the falling boom crane when performing service.
Additional Manufacturer Narrative
Through the investigation, it was determined that the service process requires three field service engineers to perform the work.However, for this event, there were only two fses on site.The japan service team has committed to staffing service events with the recommended number of fse's moving forward.

• Brand Name: TOMOTHERAPY 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: 17922109
• Report Number: 3003873069-2023-00017
• Device Sequence Number: 2971214
• Product Code: IYE
• UDI-Device Identifier: M65810182860
• UDI-Public: +M65810182860/16D20161019K
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121934
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: H-SERIES
• 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: 09/30/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2016
• 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: Required Intervention
• Patient Sex: Unknown