MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE TREATMENT DELIVERY 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 02/10/2023

Event Type  malfunction  

Event Description

Collimator fell.

Manufacturer Narrative

Customer alleged that during a qa procedure, the fixed cone fell onto the table while the user was removing the birdcage (qa equipment).There was no patient involved since this was during qa.The user confirmed there was no injury.The investigation is in process.

Manufacturer Narrative

Customer alleged that during a qa procedure, the fixed cone fell onto the table while the user was removing the birdcage (qa equipment).There was no patient involved since this was during qa.The user confirmed there was no injury.The investigation is in process.It was verified that this issue could only occur by releasing the latch.The nut is not used in this configuration, therefore the customer allegation that the nut failed is incorrect.It was verified that the latch on this system was functioning properly at the time of the event.The issue can be attributed to the therapist not being experienced and accidentally actuating the latch release, causing the cone to fall, which can occur on the vsi systems only, not m6.This has been verified with sme's from both engineering and physics.Based on the investigation, this was a use error only.

• 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: 16524783
• MDR Text Key: 311258088
• Report Number: 3003873069-2023-00002
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122137
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2018
• 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