LEKSELL GAMMAPLAN

Additional Manufacturer Narrative

H6 UPDATED. H11 UPDATED: DUE TO AN ADMINISTRATIVE ERROR, THE REPORT NUMBER SHOULD HAVE BEEN SUBMITTED AS 3015232217-2025-00063 INSTEAD OF 3015232-2025-00063. AN INITIAL REPORT WILL NOW BE SUBMITTED UNDER 3015232217-2025-00063 TO CORRECT THIS ERROR. THIS CASE HAS BEEN SUBMITTED AS A FINAL REPORT TO COMPLETE THE REPORTING PROCESS. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT AN OBSOLETE STEREOTACTIC REFERENCE WAS USED FOR TREATMENT. IT WAS ASCERTAINED THAT A TREATMENT PLAN WAS CREATED USING FRAMELESS MRI IMAGES, G-FRAME FIXATION, AND CONE BEAM COMPUTED TOMOGRAPHY (CBCT) AS THE STEREOTACTIC REFERENCE. DURING THE PLANNING PROCESS, THE CUSTOMER ELECTED TO REPOSITION THE FRAME AND ACQUIRED A NEW CBCT. HOWEVER, DUE TO A USE ERROR, THE TREATMENT PLAN WAS NOT CORRECTLY UPDATED TO REFLECT THE NEW FRAME POSITION. AS A RESULT, THE TREATMENT WAS DELIVERED BASED ON THE PREVIOUS FRAME PLACEMENT. THE PLAN HAD BEEN APPROVED AND PARTIALLY DELIVERED BEFORE THE OPERATOR IDENTIFIED THE DISCREPANCY AND PAUSED THE TREATMENT. THE SYSTEM WORKED AS DESIGNED AND INTENDED. ELEKTA HAVE NOT BEEN PROVIDED WITH INFORMATION REGARDING THE PATIENT'S CONDITION. AN IMPORTANT FIELD SAFETY NOTICE (100-01-102-019) WILL BE SENT TO ALL AFFECTED CUSTOMERS FROM 17 DECEMBER 2025 (ELEKTA REFERENCE #: FCA-ESAB-0010).

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT AN OBSOLETE STEREOTACTIC REFERENCE USED FOR TREATMENT.