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

Model Number 1536549

Device Problem Application Program Problem (2880)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2020

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 whist performing an adapt to shape position (ats) it was impossible to get a calculation (calculation failure).The customer was able to calculate once they used adapt to position (atp).  the customer also reported that the motion monitoring structure was displaced.No patients were mistreated.

Manufacturer Narrative

H6 updated.H10 updated: it was determined that tsm is causing a contour position shift relative to the images.This can occur for both single and multiple contours (for example, multiple metastatic contours or bifurcated contours).When this occurs, the position of the delineated contours with respect to the anatomy that is displayed will be erroneous.Users could make an incorrect assessment of the monitored volume position relative to the beam during treatment.This could result in a geometric miss resulting in a severity of serious mistreatment.Based on available information there was no mistreatment.Elekta recall is fca-el-0011.An important field safety notice (200-01-801-010) was released in august 2020.An ifsm is estimated to be released april 2021.

• Brand Name: ELEKTA UNITY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 9882880
• MDR Text Key: 200760521
• Report Number: 9617016-2020-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 05060191071321
• UDI-Public: 05060191071321
• Combination Product (y/n): N
• PMA/PMN Number: K192482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1536549
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1