BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEKTA MEDICAL LINEAR ACCELERATOR

    MDR report key: 17660961 · Received August 31, 2023

    Report

    Report Number
    9612186-2023-00007
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    June 20, 2023
    Report Date
    October 26, 2023
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    UDI-DI
    05060191071017
    PMA / PMN Number
    K131965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE INVESTIGATION FOUND THAT DURING SERVICE ACTIVITIES, TWO RADIOTHERAPISTS ENTERED THE TREATMENT ROOM. AN ELEKTA FIELD SERVICE ENGINEER WAS COMPLETING SERVICE ACTIVITIES AND STARTED DELIVERING A BEAM WITHOUT REALISING THAT ONE OF THE RADIOTHERAPISTS WAS STILL PRESENT IN THE TREATMENT ROOM. THE RADIOTHERAPIST WAS PERFORMING POSITIONING ACTIVITIES TO THE LINAC WHICH WOULD INDICATE THEY WERE NOT STANDING IN IMMEDIATE VICINITY OF THE GANTRY. ONCE THE RADIOTHERAPIST HEARD THE AUDIBLE NOISE FROM THE LINAC INDICATING THAT A BEAM HAD BEEN STARTED THEY RAN TOWARDS THE TREATMENT ROOM MAZE TO DISABLE THE BEAM VIA THE EMERGENCY STOP BUTTON BUT THEY SAW THE OPEN DOOR BUTTON AND PRESSED THAT INSTEAD. THE FIELD SERVICE ENGINEER TURNED OFF THE BEAM VIA THE CONSOLE ONCE THEY HEARD SOMEONE SHOUTING FROM THE TREATMENT ROOM. THE BEAM WAS ON FOR APPROXIMATELY THREE SECONDS. THE HOSPITAL'S RADIATION SAFETY OFFICER (RSO) ADVISED THAT THE RADIOTHERAPIST'S RADIATION DETECTION BADGE THAT THEY WERE WEARING AT THE TIME OF THE EVENT BE SENT TO THE VENDOR FOR AN IMMEDIATE READING. ELEKTA HAVE CONCLUDED THAT NO NEW RISKS HAVE BEEN IDENTIFIED AND THAT THIS INCIDENT WAS DUE TO USE ERROR. FACILITIES SHOULD HAVE PROTOCOLS IN PLACE WHEN A LINAC IS BEING SERVICED NOT TO ENTER THE TREATMENT ROOM. ACTUAL INJURY WAS SUSTAINED TO A RADIATION THERAPIST BUT THE AMOUNT OF UNINTENDED RADIATION EXPOSURE IS UNKNOWN TO ELEKTA, ALTHOUGH THE RSO DETERMINED THAT THE EXPOSURE LEVEL WAS VERY MINIMAL.

    Additional Manufacturer Narrative · 0

    DUE TO AN ADMINISTRATIVE ERROR ELEKTA REF. (B)(4) HAS BEEN INCORRECTLY SUBMITTED UNDER MFR REPORT NO. 9612186-2023-00007 (ELEKTA INSTRUMENT AB) ON 31ST AUGUST 2023, AND SHOULD HAVE BEEN SUBMITTED UNDER MFR REPORT NO. 9617016-2023-00001 (ELEKTA LTD).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A RADIATION EXPOSURE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149493 ELEKTA MEDICAL LINEAR ACCELERATOR ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD 05060191071017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown