BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S.I.T. - SORDINA IORT TECHNOLOGIES SPA

    MDR report key: 6416778 · Received March 20, 2017

    Report

    Report Number
    3010625741-2017-00001
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 14, 2017
    Manufacturer
    S.I.T. - SORDINA IORT TECHNOLOGIES SPA
    Product Code
    IYE
    PMA / PMN Number
    K110840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED DURING AN IORT TREATMENT ON THURSDAY (B)(6) 2017 WITH LIAC SN (B)(4), INSTALLED IN (B)(6) MEDICAL CENTER - (B)(6), PERTAINS TO AN INTERRUPTED TREATMENT. THE PRESCRIBED DOSE WAS 23.3 GY @ R100. THE DELIVERED DOSE HAS BEEN 6 GY @ R100. DURING A TECHNICAL ANALYSIS ON LIAC SN (B)(4), CARRIED OUT ON INSTALLATION SITE BY THE ENGINEERS OF SIT-SORDINA IORT TECHNOLOGIES SPA ON (B)(6) 2017, IT HAS BEEN DETECTED THAT SOME CONNECTIONS OF THE WIRING INSTALLED IN THE OPERATING ROOMS WERE LOOSE. THEREFORE THE LIAC SN (B)(4) WORKED CORRECTLY CAUSING THE INTERRUPTION OF THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198876 S.I.T. - SORDINA IORT TECHNOLOGIES SPA LIAC 12 MEV IYE S.I.T. - SORDINA IORT TECHNOLOGIES SPA LIAC 12 MEV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR