inforMED
MalfunctionMUJ

MONACO

Received Sep 5, 2025 · Event occurred Aug 7, 2025

Report 3015232217-2025-00057 · MDR key 22976758

Device

Generic name

System, Planning, Radiation Therapy Treatment

Lot number

6.2.2.0

Product problems

  • Application Program Problem: Parameter Calculation Error
  • Insufficient Device Problem Information
  • Application Program Problem: Parameter Calculation Error
  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Insufficient Information
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Insufficient Information
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE ADAPT SETUP MEAN ED FOR EXTERNAL CONTOUR IS DIFFERENT FOR TWO IDENTICAL STUDY SETS.

Additional Manufacturer Narrative

H4: MANUFACTURING DATE IS NOT ON THE LABEL, BUT IT IS KNOWN SO FIELD H4 HAS BEEN COMPLETED WITH THIS INFORMATION. THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

Additional Manufacturer Narrative

H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT. THE CUSTOMER REPORTED THAT THE ADAPT SETUP MEAN ELECTRON DENSITY (ED) FOR THE EXTERNAL CONTOUR IS DIFFERENT FOR TWO IDENTICAL STUDYSETS. AFTER RE-CONTOURING IN AN ADAPTIVE PLAN (IN ADAPT SETUP TAB), IF THE USER SWITCHES A STRUCTURE TO OR FROM THE INTERNAL AND EXTERNAL TYPES, THE AVERAGE DENSITY IS NOT RECALCULATED TO ACCOUNT FOR UNSPECIFIED VOXELS (UNSPECIFIED VOXELS ARE NOT INCLUDED IN CONTOURED STRUCTURES). AS A RESULT, A PLAN MAY BE APPROVED WITH INCORRECT AVERAGE DENSITY VALUES. THE ISSUE OCCURS WHEN THE USER CHANGES STRUCTURE TYPE. MONACO WILL NOT RECALCULATE MEAN ED. IF THE STRUCTURE IS CHANGED, THEN THE AVERAGE DENSITY SHOULD CHANGE. THIS COULD CAUSE A PROBLEM BECAUSE THE AVERAGE DENSITY COULD BE INCORRECT. ED CALCULATION IS ONLY TRIGGERED BY ENABLING THE CONTOURING TOOL. BASED ON AVAILABLE INFORMATION THERE WAS NO MISTREATMENT. THE DEFECT THAT CAUSES THE DENSITY VALUES NOT TO BE AUTOMATICALLY RE-CALCULATED WHEN A STRUCTURE IS SWITCHED TYPE WILL BE FIXED IN A FUTURE RELEASE. THE MEAN ED COLUMN VALUES ARE INTENDED AS SUGGESTIONS ONLY. IT IS THE USER'S RESPONSIBILITY TO REVIEW ED VALUES AS ONLY THE USER CAN DETERMINE IF THEY ARE ACCEPTABLE FOR USE IN A SPECIFIC CLINICAL SITUATION. THE RELEVANT WARNINGS ARE COVERED IN THE INSTRUCTIONS FOR USE: WARNING 1.1. ALL PLANS MUST BE VALIDATED FOR CORRECTNESS, INCLUDING A SECONDARY MONITOR UNIT CHECK, BY QUALIFIED PERSONNEL BEFORE CLINICAL USE.