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

Lot Number 152344

Device Problems Output Problem (3005); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Aktina a 3rd party supplier of cones, have changed their density release inspection method for detecting beam cone voids.The cones are integrated into elekta medical linear accelerator where the planned radiation dose is directed through the cone.The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Manufacturer Narrative

H2 updated.H6 updated.H10 updated: the product of concern, interlocked circular small field collimators, is one that is sold to elekta customers alongside the elekta product range.Elekta has been pursuing this issue with the legal manufacturer aktina medical corporation.Aktina medical corporation has a plan of action to re-check demonstration of compliance to iec 60601 between the old and new production methods.It will be up to aktina medical corporation to pursue any field actions that are deemed appropriate.If there are no affected product identified in the united states, fda will not hear any further on this issue from elekta or aktina medical corporation.

• Brand Name: ELEKTA MEDICAL LINEAR ACCELERATOR
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgaten 18; sweden, 103 9 3; SW 103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; kungstensgatan 18; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL,
• MDR Report Key: 15130722
• MDR Text Key: 302329736
• Report Number: 3015232217-2022-00010
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K210500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 152344
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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