MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB ELEKTA MEDICAL LINEAR ACCELERATOR; ACCELERATOR, LINEAR, MEDICAL

Lot Number 156780

Device Problems Computer Software Problem (1112); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

The customer reported a rattling sound when the gantry rotates.

Manufacturer Narrative

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

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer informed that a therapist heard a loud clunk, then heard rattling when rotating the gantry.It was then discovered that the multileaf collimator (mlc) bank fixing on one corner out of the four was loose and a shim had fallen off.The mlc bank is made up of x1 1 mm shim and x1 2mm shim on each head to create a 3mm stack either side.Upon installation the 1mm and 2mm shims are fitted and tightened in all four locations.The investigation found that a 1mm shim appears to have fallen off due to the fixings working lose over time, on one corner the remaining three were tight.Which then resulted in a twisted mlc bank.There was no patient involved at the time the incident occurred.Elekta found that there are no torque settings in the assembly instructions to secure the leaf bank.The assembly instructions will be updated.Elekta performed a risk assessment and assessed the severity of clinical mistreatment to be "major" and probability to be "incredible (low risk).The risk assessment concluded that this is within the acceptable region.For this specific incident that occurred at this customer's site where the loose fixing and the 1mm shim falling out resulted in a twisted leaf bank would not have resulted in a clinically significant error.

• Brand Name: ELEKTA MEDICAL LINEAR ACCELERATOR
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 1b; stockholm, 10393 ; SW 10393
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; kungstensgaten 18; stockholm, 103 9 3; SW 103 93
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 16944784
• MDR Text Key: 315689535
• Report Number: 3015232217-2023-00030
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 05060191071574
• UDI-Public: 0105060191071574
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 156780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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