BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL GAMMA KNIFE

    MDR report key: 2602504 · Received May 30, 2012

    Report

    Report Number
    9612186-2012-00002
    Event Type
    Other
    Date Received
    May 30, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS SITUATION IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION HAS BEEN COMPLETED, MORE DETAILS AND A CONCLUSION WILL BE PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DATA IS MISSING FROM THE TREATMENT PROTOCOL PRINTOUT. IT IS UNKNOWN AT THIS TIME WHETHER THIS COULD HAVE LED TO AN ADVERSE EVENT. INITIAL ASSESSMENT SHOWS THAT THERE MAY BE A RISK THAT TOO MUCH RADIATION COULD HAVE BEEN GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA KNIFE SYSTEM, RADIATION THERAPY, RADIONUCLIDE IWB ELEKTA INSTRUMENT AB 4C NA

    Patients

    Seq Age Sex Outcome Treatment
    1