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

Model Number G4

Device Problem Unintended System Motion (1430)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

Customer alleged the standard treatment couch has excessive movement when rolling left to right.No patient was involved, and no injury was reported.Investigation is ongoing.

Event Description

Standard treatment couch (stc) had excessive movement when rolling left to right.

Manufacturer Narrative

It has been determined that this issue occurred due to field service engineer error in performing the stc (standard treatment couch) set screw investigation as part of the pm that occurred 78 days prior to this issue being reported.

• 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: 16550413
• MDR Text Key: 311379860
• Report Number: 3003873069-2023-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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