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

Lot Number	156780
Medical Device Problem Codes	Computer Software Problem (1112); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a rattling sound when the gantry rotates.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional 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
• Common Device Name: 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
• Report Number: 3015232217-2023-00030
• Device Sequence Number: 15047008
• Product Code: IYE
• UDI-Device Identifier: 05060191071574
• UDI-Public: 0105060191071574
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K210500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Lot Number: 156780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown