BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEKTA MEDICAL LINEAR ACCELERATOR

    MDR report key: 16944784 · Received May 17, 2023

    Report

    Report Number
    3015232217-2023-00030
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 17, 2023
    Report Date
    October 25, 2023
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    05060191071574
    PMA / PMN Number
    K210500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER INFORMED THAT A THERAPIST HEARD A LOUD CLUNK, THEN HEARD RATTLING WHEN ROTATING THE GANTRY. IT WAS THEN DISCOVERED THAT THE MULTILEAF COLLIMATOR (MLC) BANK FIXING ON ONE CORNER OUT OF THE FOUR WAS LOOSE AND A SHIM HAD FALLEN OFF. THE MLC BANK IS MADE UP OF X1 1 MM SHIM AND X1 2MM SHIM ON EACH HEAD TO CREATE A 3MM STACK EITHER SIDE. UPON INSTALLATION THE 1MM AND 2MM SHIMS ARE FITTED AND TIGHTENED IN ALL FOUR LOCATIONS. THE INVESTIGATION FOUND THAT A 1MM SHIM APPEARS TO HAVE FALLEN OFF DUE TO THE FIXINGS WORKING LOSE OVER TIME, ON ONE CORNER THE REMAINING THREE WERE TIGHT. WHICH THEN RESULTED IN A TWISTED MLC BANK. THERE WAS NO PATIENT INVOLVED AT THE TIME THE INCIDENT OCCURRED. ELEKTA FOUND THAT THERE ARE NO TORQUE SETTINGS IN THE ASSEMBLY INSTRUCTIONS TO SECURE THE LEAF BANK. THE ASSEMBLY INSTRUCTIONS WILL BE UPDATED. ELEKTA PERFORMED A RISK ASSESSMENT AND ASSESSED THE SEVERITY OF CLINICAL MISTREATMENT TO BE "MAJOR" AND PROBABILITY TO BE "INCREDIBLE (LOW RISK). THE RISK ASSESSMENT CONCLUDED THAT THIS IS WITHIN THE ACCEPTABLE REGION. FOR THIS SPECIFIC INCIDENT THAT OCCURRED AT THIS CUSTOMER'S SITE WHERE THE LOOSE FIXING AND THE 1MM SHIM FALLING OUT RESULTED IN A TWISTED LEAF BANK WOULD NOT HAVE RESULTED IN A CLINICALLY SIGNIFICANT ERROR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A RATTLING SOUND WHEN THE GANTRY ROTATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501194 ELEKTA MEDICAL LINEAR ACCELERATOR ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 156780 05060191071574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown