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

Model Number VSI

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

The after treatment patient couch movement was caused by set screws on the connecting linkage to the roll motor that were loose.When the patient got up, they grabbed the patient right side of the couch and swung their body to patient's left.This motion dislodged the linkage that was loose.

Event Description

The patient was sitting up on the treatment couch after treatment while the staff member was at the patient's side.When the patient stood up, the couch tilted and the patient fell off the couch.

• Brand Name: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
• Type of Device: MEDICAL LINEAR ACCELERATOR
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 11277039
• MDR Text Key: 231129033
• Report Number: 3003873069-2021-00001
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: M6580330000
• UDI-Public: +M6580330000/16D20180522D
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VSI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2007
• 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