MONACO

Description of Event or Problem

THE CUSTOMER REPORTED INCORRECT PATIENT DATA LOADED IN CONTOURING.

Additional Manufacturer Narrative

THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

Additional Manufacturer Narrative

H2 UPDATED. H6 UPDATED. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED INCORRECT PATIENT DATA LOADED IN CONTOURING. THE PATIENT WAS REMOVED FROM THE TABLE BEFORE THE NEXT PATIENT (PROSTATE TREATMENT) WAS LOADED. FOLLOWING THE MRI IT WAS REALISED THAT THE DATA COMING FROM MONACO (TREATMENT PLANNING SYSTEM) BELONGED TO THE PREVIOUS CERVIX PATIENT. FOLLOWING THE RESTART OF THE DEVICE THE ISSUE DID NOT RECUR. THE CUSTOMER WAS CONCERNED THAT THERE COULD BE A POTENTIAL FOR MISTREATMENT IF TWO SIMILAR PATIENTS WITH SIMILAR TREATMENT SITES HAD THEIR TREATMENT PLANS MIXED. THE CASE WAS INVESTIGATED TO THE FULLEST EXTENT POSSIBLE WITH LIMITED INFORMATION AVAILABLE. THE ISSUE COULD NOT BE REPRODUCED AND ASSESSED AS A USAGE PROBLEM. TO MINIMISE THE RISK OF SIMILAR INCIDENTS IN THE FUTURE, IT IS THE USER'S RESPONSIBILITY TO REVIEW THE CONTOURS AND STRUCTURES PRIOR TO TREATMENT DELIVERY. THE LIKELIHOOD THAT THE LOCATION AND SIZE OF ANATOMICAL STRUCTURES WILL MATCH ACROSS DIFFERENT PATIENTS IS NEGLIGIBLE AND ANY MISMATCH WOULD BE DETECTABLE PRIOR TO USE.