BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEKTA INFINITY

    MDR report key: 23153968 · Received September 26, 2025

    Report

    Report Number
    3015232217-2025-00061
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    May 1, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    PMA / PMN Number
    K131965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DUE TO AN ADMINISTRATIVE OVERSIGHT, THIS REPORT SHOULD HAVE BEEN SUBMITTED UNDER MANUFACTURER NUMBER 9617016 AND NOT 3015232217-2025-00061. AN INITIAL/FINAL CORRECTION REPORT WILL NOW BE FILED UNDER THE CORRECT MANUFACTURER WITH THE REPORT NUMBER 9617016-2026-00002 TO ADDRESS THE ERROR. THIS CASE HAS BEEN SUBMITTED AS A FINAL REPORT TO COMPLETE THE REPORTING PROCESS. G4 UPDATED. H1 HAS BEEN UPDATED. H11 HAS BEEN UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. A THIRD-PARTY SUPPLIER (VARIAN) NOTIFIED ELEKTA THAT A CUSTOMER REPORTED THAT A PATIENT WAS TREATED WITH A TABLE POSITION 20 CM OUT OF TOLERANCE. IT WAS ASCERTAINED THAT ON (B)(6) 2025, A PATIENT WAS TREATED WITH THE TREATMENT COUCH POSITION 20 CM OUT OF TOLERANCE. THE SITE USES A STANDARD TABLE CONFIGURATION. FOLLOWING IMAGING, THE TREATMENT COMPUTER FLAGGED A LONGITUDINAL MISALIGNMENT OF APPROXIMATELY 22 CM. THE THERAPIST MANUALLY APPLIED THE SHIFT POST-IMAGING. A DOSE OF -84 CGY WAS DELIVERED TO THE TARGET BEFORE THE MISALIGNMENT WAS IDENTIFIED. THIS REPRESENTS APPROXIMATELY 50% OF THE DAILY PRESCRIBED DOSE AND 1/50TH OF THE TOTAL PRESCRIPTION, WHICH IS CONSIDERED SERIOUS MISTREATMENT. THE LINAC FUNCTIONED AS DESIGNED AND INTENDED. THE SYSTEM CORRECTLY IDENTIFIED THE TABLE POSITION AS OUT OF TOLERANCE FOLLOWING IMAGING. THE USER IS RESPONSIBLE FOR MAKING SURE THAT THE PATIENT IS POSITIONED CORRECTLY. THE INCIDENT WAS ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 0

    THE THIRD-PARTY SUPPLIER ((B)(4)) NOTIFIED ELEKTA THAT THE CUSTOMER (NAME, ADDRESS, PHONE NUMBER AND EMAIL: (B)(6)) REPORTED THAT A PATIENT WAS TREATED WITH TABLE POSITION 20 CM OUT OF TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282242 ELEKTA INFINITY ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown