BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XVI

    MDR report key: 6228623 · Received January 6, 2017

    Report

    Report Number
    9617016-2017-00001
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    December 8, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    PMA / PMN Number
    131965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS ASSESSED WITH A NO RISK SAFETY STATEMENT. DUE TO THE CONDITIONS OF HOW THIS SPECIFIC INCIDENT OCCURRED, IT REMAINS THAT THE RISK OF HARM IS ACCEPTABLE.IT IS EXPECTED THAT THE ENGINEERS ARE TAKING SUITABLE SAFETY PRECAUTIONS AND THAT GOOD ENGINEERING PRACTICE IS ALWAYS FOLLOWED WHEN PERFORMING SIMILAR SERVICE OR REPAIR ACTIVITIES ON SITE WITH RESPECT TO USING THE RIGHT TOOL, PROTECTIVE EQUIPMENT AND METHOD. THE ENGINEERS SHOULD PERFORM THEIR ACTIVITIES FOLLOWING GOOD ENGINEERING PRACTICE AND SAFETY PRECAUTIONS.

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER SUSTAINED A CUT TO HIS KNUCKLES WHEN HIS HAND SLIPPED CUTTING CABLE TIES DURING INSTALLATION OF NEW CABLES ON THE EQUIPMENT. IT REQUIRED 2 STITCHES TO THE HAND IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13724 XVI ACCELERAOR, LINEAR, MEDICAL, PRODUCT CODE: IYE IYE ELEKTA LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other