MAUDE Adverse Event Report: VARIAN VARIAN CLINAC CL-21EX; LINEAR ACCELARATOR

Model Number H27

Device Problem Use of Device Problem (1670)

Patient Problem Suture Abrasion (2497)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

The site reported to varian the issue occurred due to the therapist manually moved the couch and the patients hand/fingers were in the path of the couch movement/pinch point area.The therapist moved the couch while the patient moved their thumb into this pinch point, resulting in the patient's thumb being injured.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

Patient id (b)(6) was being treated in the prone position, on exact couch bars in.After the treatment was complete, as the therapist was moving the couch down and out (couch lng away from linac) the patient did a push up type move to relieve the stress to his back from lying prone.On the opposite side from where the therapist was standing his hand was below the table top.As the very end of the table came back toward the base a pinch point was created.The patient's thumb was injured requiring emergency room evaluation, x-ray and suture.There was a laceration but no fractures.

• Brand Name: VARIAN CLINAC CL-21EX
• Type of Device: LINEAR ACCELARATOR
• Manufacturer (Section D): VARIAN; 911 hansen way; palo alto CA 94304 1028
• Manufacturer (Section G): VARIAN; 911 hansen way; palo alto CA 94304 1028
• Manufacturer Contact: k semone ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 7961356
• MDR Text Key: 123563655
• Report Number: 2916710-2018-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H27
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2005
• 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): Required Intervention