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

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2023

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 when overwriting a plan and irradiating with consolidated field sequence (cfs) part of the plan was irradiated with the paramaters before overwriting.

Manufacturer Narrative

Section h6 updated.Section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.From the software logs it has been determined that a mistreatment occurred when two fields were treated with mosaiq auto field sequence (afs) defined consolidated field sequencing (cfs) on two days.The two fields were motorized wedge fields and the wedge out portion of treatment was delivered with an energy of 4mv instead of the intended 10mv for two fractions.When the same fields were treated individually (not in afs/cfs) on the other days of treatment, the wedge out portion was treated correctly with 10mv.When the customer updates an existing simple partial wedge treatment field definition with a new rtplan, does not open or approve the field definition in mosaiq before treatment and delivers that updated simple wedge field as part of a consolidated field sequencing afs group, the unwedged portion of that partially wedged field would deliver with the settings in the field that were there before the update.This issue was determined to be a defect in the product.Due to this defect, the patient was treated with the wrong energy.The customer reported a dose error to isocenter of 10 cgy.The intended daily dose was 300 cgy and the intended total dose was 3000 cgy so the error represents 3.3% of the intended daily dose or 0.33% of the intended total dose.Given that the defect resulted in part of the dose being delivered by a lower energy than intended, the dose error at depth to isocenter is expected to represent an underdose.Elekta physics assessed as an insignificant radiation underdose.Elekta performed a risk assessment and assessed the severity to be "serious" and probability to be "incredible" if this were to reoccur.The risk assessment concluded that the risk is considered low.A product bulletin (elekta ref: (b)(4) ) was issued to customers.The product bulletin was sent to the customer on (b)(6) 2024.The defect has been fixed in mosaiq version 2.86.

• 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: 18371093
• MDR Text Key: 331104830
• Report Number: 3015232217-2023-00075
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.040
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/21/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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