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

Model Number	H29A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abrasion (1689); Joint Dislocation (2374)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was treated on the (b)(6) machine, suffered an accident on (b)(6) 2024 at around 10:30 in the morning.It was his first session and when trying to take an image for positioning, the technicians were unable to do so due to the laserguard being activated.Therapist disabled the laserguard and took the image.When starting the treatment itself, in the arc where the accident occurred, the table was at a 20-degree angle and the technicians forgot to turn the laserguard back on.The collimator collided with the patient's elbow, causing an injury (cut) and a dislocation in the shoulder.Tests were carried out on the laserguard with the medical physics team and at no time did it fail to detect and also at no time did it fail to inform on the console display when it was deactivated (test performed 10 times).The laserguard calibration was checked and all parameters were as specified so that it was perfectly aligned.Issue attributed to user error, when user did not turn on laserguard before rotating gantry after imaging.
Additional Manufacturer Narrative
Therapist were trying to take an image for positioning, the technicians were unable to do so due to the laserguard being activated (laserguard detected objects to close to device and prevents beam on).Therapist then disabled the laserguard and took the image.When starting the treatment itself, in the arc where the incident occurred, the table was at a 20-degree angle and the technicians forgot to turn the laserguard back on.Therapist rotated gantry with laserguard off.The collimator collided with the patient's elbow, causing an injury (cut) and a dislocation in the shoulder.Tests were carried out on the laserguard with the medical physics team and at no time did it fail to detect and also at no time did it fail to inform on the console display when it was deactivated (test performed 10 times).The laserguard calibration was checked and all parameters were as specified so that it was perfectly aligned.Issue attributed to user error.Follow up on patients' injury requested and received on 6-18-2024 (site contact physicist (b)(6) provided the information) ¿ the cut on arm is healing ¿ an orthopedic professional put the patient's shoulder back in place.The patient reported they did not feel any pain in the area, but a slight discomfort due to the recent impact.

• Brand Name: CLINAC-TRILOGY
• Common Device Name: 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: 19607774
• Report Number: 2916710-2024-00002
• Device Sequence Number: 12352265
• Product Code: IYE
• UDI-Device Identifier: 00899475002066
• UDI-Public: 00899475002066
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K061140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H29A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown