MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS CLINAC-21EX; LINEAR ACCELERATOR

Model Number H29

Device Problem Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/22/2023

Event Type  Injury  

Event Description

Information provided by(b)(6) 2023 (aware date): event date:(b)(6) 2023.- sequence of events leading to the injury.The couch was angled and the therapist didn't perceive and rotated the gantry - information about the patient's treatment.Id1:(b)(6) / id2: (b)(6).- plan information logs provided.- injury details patient had a nose injury, crushed nose leading to a light fracture.- was any medical intervention necessary after the incident? information provided by on (b)(6) 2023: he reports she did not need any surgical procedures, dressing or suturing.Emphasized that the patient is very well.The customer mentioned the problem was human error and the machine have no errors.

Manufacturer Narrative

The reported issue indicated after treating a first field at 15° (iec scale) the user was moving the gantry downwards to prepare for the second field at 90° (iec scale).He was expecting a seamless rotation, however a collision occurred, which injured the patient laying on the couch.- the investigation confirmed the issue did occur.- the cause of the issue is user error.The logs reveal that a first field was delivered with the gantry at 15° (iec scale) and the couch at 269.9° (iec scale).The following field demanded gantry=90° and couchrtn=0° (iec scale).The therapist directly started to move the gantry instead of first moving the couch out of the way.This led to a collision at a gantry angle of 50° (iec scale).Varian has addressed this issue giving clear instructions how to avoid collisions in the ifu (see attached screenshots) to mitigate the risk of collisions varian has implemented exclusion zones for gantry and couch position (see attached fig.16 exclusion zones).For this safety mechanism to work both gantry and couch must be in the same hemisphere (see attached fig.13 exclusion zones).- when the issue occurs, the user will see a collision between couch and gantry.And in the worst case as it happened here a collision with the patient.- the ifu customer documentation has instructions giving advice how to avoid collisions.Namely in ifu document ¿100019593-12-rev_8.0-trilogy_and_clinac_ix_instructions_for_use¿ giving instruction how to prevent collisions.Refer to page 52 as well as 220-221.The injury was minor and did not require medical intervention including no dressings, splints, or surgery.So in this case, there were no serious adverse health consequences due to this use error.Varian is conservatively reporting as it was a non-serious fracture.There has been no report or finding that the varian device has malfunctioned.This issue is attributed to human error.

• Brand Name: CLINAC-21EX
• Type of Device: LINEAR ACCELERATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 17607352
• MDR Text Key: 321803689
• Report Number: 2916710-2023-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00899475002042
• UDI-Public: 00899475002042
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H29
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2023
• 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
• Patient Sex: Female