BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION LIGHT

    MDR report key: 11211032 · Received January 21, 2021

    Report

    Report Number
    2028295-2021-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 30, 2020
    Report Date
    January 19, 2021
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FTD
    PMA / PMN Number
    K930897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD FAILURE OD A 21ST CENTURY CENTURION DUAL LIGHT SYSTEM (MODEL: 021515 / S/N: (B)(4)) ARM WAS RECEIVED INTO ENGINEERING FOR FAILURE ANALYSIS. THE CUSTOMER STATES THAT THE UNIT HAS BEEN INSTALLED IN AN EXAMINATION ROOM AND HAD NORMAL USAGE OVER THE PAST TWO DECADES WITH NO INSADENTS. THE FAILED COMPONENT WAS IDENTIFIED AS THE ARM SUPPORT FITTING, (B)(4) A COMPONENT OF THE SPRING ARM WHERE THE EXTENSION ARM ASSEMBLY ATTACHES TO THE SPRING ARM. THE SPRING ARM ASSEMBLY WAS DISSASSEMBLED AND ALL COMPONENTS WERE VISUALLY EXAMINED. OTHER THAN THE ARM SUPPORT FITTING (B)(4), NO ANOMALIES WERE FOUND. THE ENTIRE ARM SUPPORT FITTTING WAS VISUALLY INSPECTED UNDER 30X MAGNIFICATION AND THEN CUT INTO SECTIONS AT HIGHEST "LOAD" POINTS ON THE UNIT TO INSPECT FOR POROSITY. THE ANALYSIS INDICATED THE FOLLOWING. THE UNIT WAS VISUALLY INSPECTED, THE MATERIAL WAS CONSISTENT IN COLOR WITH VIRGIN RAW ALUMINUM. THE FAILURE WAS IDENTIFIED AT A POINT THAT CONTAINED A VOID IN THE MATERIAL. THE VOID APPEARS TO HAVE BEEN FORMED BY THE PARTIAL SOLIDIFICATION OF MOLTEN ALUMINUM DURING THE CASTING PROCESS. THE BREAK AREA APPEARS TO HAVE SEVERAL MICO-CRAKS RADIATING OUTWARDS FROM THE FULCRUM HOLE. THIS HAS BEEN SEEN BEFORE IN DESTRUCTION TESTS WHEN THE CENTER-BOLT WAS OVERTIGHTEN. HOWEVER, THE CUT-SECTIONS WERE INCONCLUSIVE IN THAT IT COULD NOT BE DETERMINED THE ACTUAL DEPTH OF THOSE CRACKS. WE ATTRIBUTE THAT THE FAILURE WAS THE DIRECT CAUSE OF THE VOID FOUND IN THE BROKEN ARM SUPPORT FITTING COMPONENT. THIS FAUIT COULD NOT HAVE BEEN IDENTIFIED IN THE INCOMING INSPECTION OR BY THE ASSEMBLER. IN SPEAKING WITH THE SUPPLIER OF THE COMPONENET, HE AGREED THAT THE VOID WAS LIKELY CAUSED BY THE PARTIAL SOLIDIFICATION OF THE MATERIAL SAYING THAT THIS WAS CONSISTENT WITH A PAUSE IN THE POURING PROCESSES.

    Description of Event or Problem · 1

    ON DECEMBER 30TH, IT WAS REPORTED TO MEDICAL ILLUMENATION THAT A CENTURION LIGHT HAD A BROKEN ARM SUPPORT FITING AND WAS BEING SENT IN FOR REPAIR. NO INJURIES OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108090 CENTURION LIGHT SURGICAL LIGHT FTD MEDICAL ILLUMINATION INTRNATION INC. 021515

    Patients

    Seq Age Sex Outcome Treatment
    1