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

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that offsets were not sent to the accelerator after matching.It was ascertained from the mosaiq logs that during a single fraction course of radiation therapy intended to treat c1 and c2 a use error lead to a geometric miss of the target volume.The patient was placed on the treatment couch and then treated without being positioned in the correct treatment position.The mosaiq couch move assist tools were not used.The location of the treatment cannot be determined from the information provided.The customer has not reported any injury, or adverse sequalae, to the patient.During a course of single fraction radiation therapy a use error has caused the treatment target to be missed, a serious mistreatment by definition.Mosaiq is working as designed.The shifts were not applied as intended and mistreatment occurred due to use error.

Event Description

The customer reported that offsets were not sent to the accelerator after matching.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 17697098
• MDR Text Key: 322802156
• Report Number: 3015232217-2023-00052
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002336
• UDI-Public: (01)00858164002336(10)2.82.108
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• 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