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

Model Number	1536549
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem 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.
Additional 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
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• MDR Report Key: 9882880
• Report Number: 9617016-2020-00002
• Device Sequence Number: 19520686
• Product Code: IYE
• UDI-Device Identifier: 05060191071321
• UDI-Public: 05060191071321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Model Number: 1536549
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1