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

Device Problem Noise, Audible (3273)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2020

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

The customer reported that the gantry noise caused by steel ball embed into the drum.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information and it was ascertained that elekta infinity was working as designed and intended.A steel ball found embedded in a gantry rim was removed before meaningful tests could be conducted on site.Subsequent iso-centre measurements showed that the machine was within specification and no significant damage had been done.The fault was introduced to a machine in a test shelter.There was a negligible effect (0.01cm) on iso-centre accuracy during an image acquisition using a pelvis phantom.A mechanical iso-centre test showed that there was a resulting change in source to surface distance of up to 2mm and it is calculated that this could result in clinically insignificant errors of 0.4% in the delivered dose and 0.2% in the field size.This would only happen at a specific gantry rotation angle of 110° and significant mistreatment to a patient is thought to be extremely unlikely.

• Brand Name: ELEKTA INFINITY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 10249496
• MDR Text Key: 198392359
• Report Number: 9617016-2020-00005
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00506019107017
• UDI-Public: 0506019107017
• Combination Product (y/n): N
• PMA/PMN Number: K192242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1