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

Model Number M6

Device Problems Therapy Delivered to Incorrect Body Area (1508); Detachment of Device or Device Component (2907)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

Customer contacted service because they were not able to treat using the fixed collimator assembly (fca) because the laser alignment check failed.The field service engineer (fse) found the fca was mounted with one screw and three were missing.The fse replaced the housing and system is functioning.Investigation is in progress.

Event Description

Customer contacted service because they were not able to treat using the fixed collimator assembly (fca) because the laser alignment check failed.

Manufacturer Narrative

Customer contacted service because they were not able to treat using the fixed collimator assembly (fca) because the laser alignment check failed.The field service engineer (fse) found the fca was mounted with one screw and three were missing.The fse replaced the housing and system is functioning.This is a known hardware issue that occurs over time.This is an instance where the screws that hold the fca in place came loose due to incorrect screw length and improper screw engagement.The fca housing was replaced and system is functioning.In conclusion, investigation determined no patient impact.Customer only used fca for qa testing.

• 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: 16117936
• MDR Text Key: 307625028
• Report Number: 3003873069-2023-00001
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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