MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS VARIAN CLINAC 6DBX; LINEAR ACCELERATOR, PRODUCT CODE IYE, PRODUCT CODE: IYE

Model Number H18

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

The site reported to varian that the issue occurred due to the therapist manually moving the couch and the patients hand/fingers were in the path of the couch movement/pinch point area resulting in the patients finger being injured and fractured.The couch top is correctly labeled with pinch point warning stickers on the couch top.There has been no report or finding that the varian device has malfunctioned.This issue is attributed to human error.

Event Description

The patient pinched his finger while the operator moved the rails from inside to outside,.Following the pinching of the finger, the patient went to the emergency room, and the x-ray showed a fracture of a phalanx of the middle finger that had been pinched.This injury has not limited or delayed radiotherapy treatments.For privacy reasons, we were not provided with any further information regarding the diagnosis of ed.

• Brand Name: VARIAN CLINAC 6DBX
• Type of Device: LINEAR ACCELERATOR, PRODUCT CODE IYE, PRODUCT CODE: IYE
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304
• Manufacturer Contact: k. semone ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 12321778
• MDR Text Key: 266571125
• Report Number: 2916710-2021-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K904364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H18
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2021
• Date Device Manufactured: 08/25/2006
• 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