MAUDE Adverse Event Report: ELEKTA LTD PRECISE SERIES LINAC; ACCELERATOR, LINEAR, MEDICAL

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2014

Event Type  No Answer Provided  

Event Description

On the (b)(6) because of intermittent diaphragm rotation inhibits, the service engineer changed and calibrated the coarse check and fine potentiometers.The calibration was checked and found to be ok.The calibration was also checked by the hospital physicist later on in the evening and found to be ok.No problems occurred until (b)(6) 2014 when the customer reported that the head angle was ok in the morning, but a shift of 7° occurred in the afternoon.Verification via remote phone call found that coarse and check potentiometers were still at 5.00 v at a head angle of 0°.The service engineer lead the customer through the calibration procedure, and after the calibration everything seemed to be normal again.

Manufacturer Narrative

The manufacturer's analysis has found that on (b)(6) (a.M.) the online matching with drrs (digitally reconstructed radiograph) showed the last patient before lunch was setup correctly with no positioning error.On (b)(6) (p.M.) the customer reported visual error with the collimator alignment.The projected field was not parallel to the imaging panel edges as it should have been.The manufacturer has not identified a root cause for this issue.Based on the information that has been provided the manufacturer concludes that this error was caused by a mechanical fixation not correctly carried out by the service engineer whilst completing maintenance upon the collimator assembly.The service engineer maintains that the assembly was fitted correctly but with the sequence of events: that the system was correct in the morning, then misaligned in the afternoon and subsequently resolved by carrying out a calibration.This series of events can be explained if the assembly was not correctly fitted i.E.The fine potentiometer assembly was not fully screwed together, and through slipping the assembly rotated causing the fault.A subsequent re-calibration of the collimator fine potentiometer after this scenario would cause the issue to be resolved.All fixings have now been inspected on site and the fine potentiometer replaced and re-calibrated.The fault has not reoccurred.The manufacturer will be carrying out a mandatory field safety corrective action for another issue relating to potentiometer assembly, this will involve a mandatory training course for all service engineers to reinforce the correct fixation method and the potential consequences of not correctly fitting these assemblies.The time schedule for this action is end of december 2014.

• Brand Name: PRECISE SERIES LINAC
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 4230032
• MDR Text Key: 5070329
• Report Number: 9617016-2014-00012
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K963624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/06/2014

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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