MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. CLINAC; ACCELERATOR, LINEAR, MEDICAL

Model Number H29

Device Problem Unintended Collision (1429)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A follow-up to this mdr is expected upon completion of the investigation.

Event Description

It was reported the patient was on the treatment table when the therapist rotated the gantry from the control console and collided the gantry into the patients head while not observing the patient with the cctv (closed circuit television).The patients head was reported injured, and a bone was reported as fractured.At this time the site has neither provided the identity of the bone nor any details of the injury.

Manufacturer Narrative

There was no failure or malfunction of varian hardware or software.This event occurred as a result of user error.The operator failed to monitor the patient during remote gantry rotation as directed by existing product labeling.No additional information regarding patient injury was made available.No additional follow up to this report is anticipated.Varian reference (b)(4).

• Brand Name: CLINAC
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.; 911 hansen way; palo alto CA 94304 1028
• Manufacturer (Section G): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304 1028
• Manufacturer Contact: k. semone ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 5243844
• MDR Text Key: 31966231
• Report Number: 2916710-2015-00004
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K131807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: H29
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2006
• 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
• Patient Outcome(s): Other