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

Device Problem Device Handling Problem (3265)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The customer reported that after taking the port film that the jaws did not close down.After inspecting images, the customer noticed that the port film had listed two open fields, when there should be a planned and open field.The customer checked the field in mosaiq and the true open field dimensions were correct, but the second open field that should be the planned field had the dimensions of planned field but the jaws were out of position.

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 reported that after taking port film the jaws did not close down.Upon inspecting images the customer noticed that port film listed two open fields when there should be a planned and open field.The investigation resulted in review of both machine logs and software logs (mosaiq).From the linac investigation it has been established that the machine delivered the prescribed dose and was therefore working as designed and intended.Further investigation into mosaiq (software) ascertained that after the console setup was completed, while the jaws were still moving to the target positions, the jaw movement stopped.The jaws had not reached the intended target position for the planned port film when the exposure was given.The root cause appears to be directly linked to completing console setup with the 'set up mechanical parameters with treatment values' option and is not specific to an override.The issue is the result of the user's workflow.The image that is saved in the image list is a recording of the treatment.If this issue were to re-occur it would not lead to mistreatment.Mosaiq worked as designed and intended.The reported problem is limited to portal imaging which does not impact actual treatment.Based on available information there was no patient mistreatment.

• Brand Name: ELEKTA MEDICAL LINEAR ACCELERATOR
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgaten 18; po box 7593; stockholm, 103 9 3; SW 103 93
• 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: 17668769
• MDR Text Key: 322481594
• Report Number: 3015232217-2023-00051
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00560619071512
• UDI-Public: 0560619071512
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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