MAUDE Adverse Event Report: ELEKTA LTD XVI; ACCELERATOR, LINEAR, MEDICAL

Lot Number 336025

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported that the xvi panel extended longitudinally while arm was folded in, and crashed into the patient table.Based on the available information there have been no actual mistreatment.

Manufacturer Narrative

The customer returned the xvi arm assembly for investigation, however from the condition of the returned part it was not possible to re-create the incident.The root cause of this isolated incident could not be established from the parts returned, nor could it be recreated by fitting the assembly on a life-test machine and rotating for the equivalent of 12 months.It would appear that the solenoid pin was retracted allowing the incident to occur but then extended instantly after the event.This is not the expected behaviour of the system and could not be re-created when testing the device.It can be concluded that the solenoid locking pin was not extended through the middle arm assembly locking it in place at the time of the incident and the reason for this cannot be established.The linac was taken out of service immediately after the event and the xvi arm assembly was secured mechanically in the unfolded, extended position.This ensured the xvi arm assembly was safe and the linac returned to clinical use.A new designed xvi arm assembly was fitted to the linac in july 2018.The linac is fully operational and no further incidents have been reported at this site.A new design change to ensure the micro-switch assembly is correctly setup was introduced from november 2017 (for future release product) the locking solenoid pin is fully engaged in the interface plate which secures the middle arm in place once it has been retracted/folded.(b)(4) - notification to the field that there was a potential for the uncontrolled extension of the iviewgt / xvi arm was released december 2017.(b)(4) - notification to the field on how to check that the middle arm micro-switch assembly is correctly setup to ensure the solenoid locking pin is fully engaged with the interface plate securing the middle arm in position was released april 2018.Both the ifsn and ifsm were received by this site and implemented prior to the incident occurring.

• Brand Name: XVI
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 7684986
• MDR Text Key: 113880271
• Report Number: 9617016-2018-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K131965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 336025
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1