MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS VARIAN CLINAC 21-EX; LINEAR ACCELERATOR, PRODUCT CODE IYE

Model Number H27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Site reported to varian the issue occurred due to radiologic technologist manually moved couch top and did not observe the patient's hand/finger was in the path of the couch top.Radiologic technologist manually moved couch top to collide with patient's hand/finger resulting in a broken finger.There has been no report or finding the varian device has malfunctioned, and the issue is attributed to human error.

Event Description

Radiological technologist was moving the varian couch top in manual mode.The patient's left hand was in path of the couch top movement.Radiological technologist pushed couch top and collided with patient's left hand and resulted in a broken finger, and patient's finger nail peeled off.No additional injuries were identified.

• Brand Name: VARIAN CLINAC 21-EX
• Type of Device: LINEAR ACCELERATOR, PRODUCT CODE IYE
• Manufacturer (Section D): 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: 7160705
• MDR Text Key: 96332915
• Report Number: 2916710-2017-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904364
• 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
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: H27
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2003
• 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 Age: 70 YR