BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE LINAC

    MDR report key: 4897828 · Received July 8, 2015

    Report

    Report Number
    9617016-2015-00008
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ELEKTA LTD
    Product Code
    IYE
    PMA / PMN Number
    K051932
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SOURCE OF THE ERROR IS HUMAN SO THE STARTING LIKELIHOOD IS PROBABLE. TOUCHGUARDS ARE ADDED PREVENTATIVE MECHANISMS THAT CANNOT POSSIBLY DETECT ALL COLLISIONS WITH THE BLD. IT IS TYPICAL TO CHECK FOR CLEARANCE BEFORE PERFORMING AN ASU AND GIVEN THAT THE PERSON OPERATING THE MACHINE IS A TRAINED USER, THE LIKELIHOOD OF A COLLISION IS REDUCED TO OCCASIONAL. IN MOST CASES, THE OPERATOR CONTROLS THE MACHINE EITHER FROM THE TREATMENT ROOM OR FROM THE CONTROL ROOM BY WATCHING THE CCTV. SO, THE LIKELIHOOD OF A COLLISION IS FURTHER REDUCED TO REMOTE. THE LIKELIHOOD OF PROBLEM RE-OCCURRENCE WHEREIN ALL FOUR MICRO-SWITCHES WERE BADLY ADJUSTED SUCH THAT PULL/LATERAL ACTIVATION IS NOT DETECTED AND THE TOUCHGUARD RING COLLIDED WITH THE PATIENT IN LATERAL DIRECTION IS IMPROBABLE. THE WORST CASE SEVERITY OF SUCH A COLLISION WITH THE PATIENT WOULD BE MAJOR. THEREFORE, IN WORST CASE SCENARIO, THE ESTIMATED LEVEL IS RV4 (MAJOR * IMPROBABLE).

    Description of Event or Problem · 1

    UPON ROTATION OF THE ACCELERATOR, THE MACHINE HEAD HAS COMPRESSED THE ABDOMEN OF THE PATIENT. THE TOUCHGUARD DID NOT INTERRUPT THE MOVEMENT OF THE ACCELERATOR (HEAD). THE PATIENTS ABDOMEN WAS COMPRESSED, THEY URINATED ON THE TABLE, AND THEIR BACK WAS HURT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441691 PRECISE LINAC ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other