BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-15 (CENTURION EXCEL) SUGICAL LIGHT

    MDR report key: 8614072 · Received May 15, 2019

    Report

    Report Number
    2028295-2018-00006
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    May 17, 2018
    Report Date
    June 8, 2018
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FTD
    PMA / PMN Number
    K930897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARM ASSEMBLY FROM CUSTOMER COMPLAINT (#(B)(4)) WAS RECEIVED AND IDENTIFIED AS A SIGLE 21ST CENTURY CENTURION LIGHT SYSTEM (MODEL 021514, S/N: (B)(4)). THE UNIT WAS HUNG AND VISUALLY INSPECTED AS A SYSTEM. AFTER WE MADE OUT INITIAL VISUAL OBSERVATIONS, WE PERFORMED AN IN-DEPTH ANALYSIS ON THE FAILURE. THE ARM SUPPORT FITTING ((B)(4)) WAS IDENTIFIED AS THE FAILED COMPONENT. WE INSPECTED THE COMPONENT AT THE BREAK AND FOUND NO EVIDENCE OF POROSITY OR IRREGULAR MATERIAL FLOW IN THE AREA. IN OUR ANALYSIS WE OBSERVED SURFACE DAMAGE CONSISTING OF DEEP CIRCULAR GOUGES IN THE AREA UNDER THE NUT ATTACHED TO THE COUPLING BOLT. THIS WOULD BE INDICATIVE OF AN OVERTIGHTENED CONDITION WHICH WOULD STRESS THE CASTED ALUMINUM TANGS TO A POINT OF FAILURE. WE HAVE WITNESSED THIS BEFORE WHEN A CUSTOMER ATTEMPTED TO INCREASE THE FRICTION LEVEL OF THE SUSPENSION ARM TO MINIMIZE HORIZONTAL DRIFT. HOWEVER, WE COULD NOT DEFINITELY PROVE THIS THEORY IN THAT WE ONLY OBSERVED THE VISUAL INCONGRUITY WHILE THE STRESS FRACTURES IN THE COMPONENT WERE NOT READILY APPARENT. NOTE: THIS REPORT IS LATE BECAUSE IT WAS SENT TO THE TEST EMDR INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    ON MAY 17TH AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING CENTURY CENTURION LIGHT SYSTEM ARM THAT HAD BROKEN AND GRAZED THE DOCTORS SHOULDER. WE CONTACTED THE FACILITY AND SPOKE WITH THE DOCTOR TO SEE IF ANY INJURIES OCCURED. HE STATED, NO INJURIES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404030 MI-15 (CENTURION EXCEL) SUGICAL LIGHT CENTURY CENTURION FTD MEDICAL ILLUMINATION INTRNATION INC. 021514

    Patients

    Seq Age Sex Outcome Treatment
    1