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

Model Number G4

Device Problem Unstable (1667)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

A mounting nut on the synchrony boom arm was loose due to the fse not retightening the nut enough.Investigation is in-progress.

Event Description

The synchrony boom arm had unintended motion.No death or serious injury was reported.

Manufacturer Narrative

The field service engineer (fse) went to service the system and found an issue that would not allow the completion of the service event.After the fse re-assembled the system it was discovered the boom arm screw as loose.The nut became loose because the fse did not tighten it enough when he worked on the device.The system has since been corrected and the loose hardware was re-tightened.No further action is required.

• Brand Name: CYBERKNIFE TREATMENT DELIVERY SYSTEM
• Type of Device: 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: 15089213
• MDR Text Key: 299659709
• Report Number: 3003873069-2022-00012
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: M6580325000
• UDI-Public: +M6580325000/16D20190227E
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1