MAUDE Adverse Event Report: ACCURAY INCORPORATED CYBERKNIFE SYSTEM

Model Number 032000-001

Device Problem Use of Device Problem (1670)

Patient Problems Radiation Overdose (1510); Radiation Underdose (2166)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Patient x was treated with a plan for patient y.Patient x was being treated for a right temporal metastasis and received patient y's plan for an acoustic neuroma on the left side.There was an underdose of the metastasis located on the right temporal lobe.There was an overdose on the left side at the level of the acoustic nerve.There are no side effects observed thus far.In an analysis of the log files, there were multiple indications to the user that the treatment plan was incorrect; alignment took a excessive time, treatment experienced many interruptions (patient out of bound, dxab errors), treatment dxab was higher than the typical is 0.1-0.2 mm, brightness and gain had been tailored to fall within threshold, visually the skull profile in the drr and in the live image did not match and the customer did not use the 'subtract mode' for performing a visual assessment (cross hairs weren't used for confirming the visual match between the drr and live images).The customer agreed that the problem was caused by human error.The user selected the wrong plan and did not check the actual number of fraction or total mu and scheduled beam progressions.The customer was informed of various methods to avoid this in the future.

Event Description

It was reported that a patient with brain mets received the wrong patient plan due to a use error.

• Brand Name: CYBERKNIFE SYSTEM
• Type of Device: CYBERKNIFE
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: adam st. sauver ; 1240 deming way; madison, WI 53714 ; 6088243417
• MDR Report Key: 8006174
• MDR Text Key: 126241441
• Report Number: 3003873069-2018-00005
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 032000-001
• Device Catalogue Number: 032000-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2011
• 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