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

Model Number MOSAIQ 2.81

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/11/2022

Event Type  Injury  

Event Description

A patients radiation treatment was delivered to the wrong location due to confusion about the fact the treatment beam isocenter differed from the imaging isocenter used for patient setup.As a result, radiation beams were delivered 2cm away from the intended target.This resulted in lack of coverage of the target by the radiation dose and treatment of an uninvolved area.Fda safety report id # (b)(4).

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; stockholm 55617 0-40
• MDR Report Key: 15834431
• MDR Text Key: 304114814
• Report Number: MW5113387
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MOSAIQ 2.81
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISOCENTER
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White