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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation found that the philips mr gradient coil termination cable connectors, nuts and washers should be fitted in a specific order and using the specific materials.Failure to follow this order may cause high electrical resistance leading to excessive heating of the connection, cables and surrounding area.The issue is with the supplied mr system where a supplier provided the incorrect material (stainless steel nut instead of brass; conductivity issue) and then some sites had the connection incorrectly assembled (order of nuts were incorrect leading to poor conductivity).Testing by the supplier of the mr system confirmed that whilst using the currently release imaging protocols the gradient coil connection that is correctly assembled but with the incorrect materials is acceptable for clinical use.Six of the fourteen affected sites that required immediate inspection had the connection incorrectly assembled, four of which were damaged due to excessive heat.No injuries have been reported by any site.Immediate corrective action was taken once this issue was identified where all affected systems were visually inspected and if necessary, the assembly order was corrected but the incorrect materials remained on the system.

Event Description

During elekta's investigation of the mr gradient coil connection issue it was identified that the gradient coil connection can heat excessively due to a change in conductivity resulting in heat damage to the cable and immediate surrounding area.

Manufacturer Narrative

The corrective actions taken as a result of investigation is that an important field safety notice (ifsn 200-01-801-008) was sent to affected customers on 6th may 2020.An important field safety modification to include the installation of the correct connection materials and that the fixing torques are applied will be completed by elekta and philips over the next 12 months.

• Brand Name: ELEKTA UNITY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 9878524
• MDR Text Key: 190843580
• Report Number: 9617016-2020-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K192482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1