BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM II

    MDR report key: 8614074 · Received May 15, 2019

    Report

    Report Number
    2028295-2018-00007
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    August 7, 2018
    Report Date
    August 22, 2018
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FSY
    PMA / PMN Number
    K003489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM II, DUAL ARM SPECIFIED IN CUSTOMER COMPLAINT #1685 WAS RECEIVED INTO THE ENGINEERING DEPARTMENT FOR ANALYSIS. THE FINISHED PRODUCT WAS A SYSTEM II, SS2S2120. THE ASSEMBLY WAS VISUALLY INSPECTED AND FOUND TO HAVE FAILED SPECIFICALLY ON THE 1001384 COLLAR, SPRING ROD PART. IN DISASSEMBLING THE (B)(4) -( ) ARTICULATING ARM S/A, THE INITIAL OBSERVATION WAS THAT ONE OF THE .188 PIN FEATURES ON THE (B)(4) COLLAR WAS BENT DOWN IN THE DIRECTION OF THE FORCE AND THE OTHER PIN FEATURE WAS COMPLETELY SHEARED OFF AND STUCK IN HOLES IN THE (B)(4) LINK BARS. THE COLLAR WAS INSPECTED FOR VOIDSIN THE MATERIAL BIT NONE WERE FOUND. IN OUR ATTEMPT TO CONTACT THE SUPPLIER TO QUESTION THE TRACEABILITY OF THE MATERIAL, WE WERE INFORMED THAT THE COMPLY IS NOW DEFUNCT. IN FURTHER ANALYZING THE FAILURE, IT WAS OBSERVED THAT THE LINK BARS PINS GOUGED THE PINS ON THE COLLAR INDICATING THAT THE LINK BARS WERE BEING PUSHED AWAY FROM THE (B)(4) PIVOT CASTING. WE ARE SPECULATING THAT THIS CONTRIBUTED TO THE FAILURE IN THAT SPRING LINKAGE WAS NO-LONGER LINEAR CAUSING EXCESSIVE STRESS, CAUSING THE PINS TO BEND AND BREAK. THE ARTICULATING ARM WAS REBUILT WITH ANEW PIVAT CASTING AND COLLAR AND TESTED WITH 180LBS OF DEAD WEIGHT (APPROX 6X LOAD). THE PINS SHOWED NO ANOMALIES SO THE ARM WAS EXERCISED FOR ABOUT 30 MINUTES AND DID NOT FAIL. WE ALSO APPLIED EXTREME LATERAL FORCE WELL ABOVE NORMAL USAGE AND WHILE THE UNIT DID NOT FAIL WE DID WITNESS THE LINK BARS DRIFTING OUT AT CERTAIN POINTS THROUGHOUT THE TEST, THE MOVEMENT WAS INFINITESIMAL AND THE LINK BARS RETURNED TO THEIR POSITIONS WHEN LATERAL FORCE WAS REMOVED. WE SPECULATE THAT THE ARM WAS LIKELY SUBJECTED TO EXCESSIVE FORCE AND IN AN ATTEMPT TO MOVE THE ARM THE COLLAR FAILED. NOTE: THIS REPORT IS LATE BECAUSE IT WAS SENT TO THE TEST EMDR INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2018 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING A SYSTEM II, SS2S2120 ARM FAILED TO HOLD POSITION AND CAME IN CONTACT WITH MEDICAL PERSONNEL'S HEAD. WE INQUIRED IF EVERYONE WAS OK, AND WERE TOLD JUST A SLIGHT HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405163 SYSTEM II SURGICAL LIGHT FSY MEDICAL ILLUMINATION INTRNATION INC. SS2S2120

    Patients

    Seq Age Sex Outcome Treatment
    1