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

Model Number G4

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Event Description

It was reported that the synchrony camera elbow joint detached.The synchrony camera boom arm had broken at the extension pole connection.No death or serious injury was reported.

Manufacturer Narrative

This is a follow-up report to add the investigation conclusion code in section h.6.

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Type of Device: MEDICAL LINEAR ACCELERATOR
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• MDR Report Key: 11369713
• MDR Text Key: 245349082
• Report Number: 3003873069-2021-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: M6580330000
• UDI-Public: +M6580330000/16D20200625A
• Combination Product (y/n): N
• PMA/PMN Number: K062514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1