BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 11405386 · Received March 3, 2021

    Report

    Report Number
    2028295-2021-00003
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 5, 2021
    Report Date
    March 2, 2021
    Manufacturer
    MEDICAL ILLUMINATION INTRNATION INC.
    Product Code
    FST
    UDI-DI
    00816835020164
    PMA / PMN Number
    K100388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT #(B)(4) WAS ISSUED FOR A MI-1000 LED LIGHT SYSTEM (MODEL: 061524, S/N:(B)(4)). THE LIGHT HEAD WAS RECEIVED AND SENT TO ENGINEERING FOR FAILURE ANALYSIS. THE CUSTOMER CLAIMS THAT THE LIGHT HAS BEEN IN SERVICE FOR ONE (1) YEAR BEFORE THE LIGHT HEAD SEPARATED FROM THE YOKE AND FELL FROM THE SPRING ARM BEING CAUGHT/SUSPENDED BY THE ELECTRICAL WIRING. THE INITIAL REVIEW WAS THAT THE YOKE (1002811) FAILED WHERE IT ATTACHED TO THE LIGHT HEAD. THE YOKE WAS NOT INCLUDED WITH THE RETURNED LIGHT HEAD SO THE ROOT CAUSE ANALYSIS CANNOT BE PERFORMED EMPIRICALLY. THE ANALYSIS BEGAN WITH THE INSPECTION OF THE LIGHT HEAD AND THE ASSOCIATED COMPONENTS RETURNED WITH THE UNIT. UPON VISUAL INSPECTION, THE RETAINING RING MEASURED CORRECTLY DIMENSIONALLY BUT WAS MIS-COLORED AND HAD VERY LITTLE SPRING TENSION WHEN EXPANDED. THE THRUST WASHERS APPEARED NORMAL DIMENSIONALLY AND VISUALLY. WE COMPARED THE RETAINING RING TO THE RETAINING RINGS THAT WE HAVE IN STOCK AND THERE IS A DISTINCT DIFFERENCE IN APPEARANCE. WE ALSO COMPARED THE SPRING-ACTION OF THE RETAINING RING IN THE FAILED UNIT TO SEVERAL OF THE RETAINING RINGS THAT WE HAVE IN STOCK AND FOUND THAT WAS A SIGNIFICANT DEGRADATION OF "MEMORY" IN THAT THE RETAINING RING DID NOT FULLY RETURN TO THE SET-SIZE. WITHOUT THE YOKE (REQUESTED ON (B)(6) 2021), WE CANNOT DEFINITIVELY DETERMINE A ROOT=CAUSE OF THE FAILURE. OUR SPECULATION IS THAT THE RETAINING RING DID NOT FULLY ACCEPT THE ANNEALING AND HEAT-TREATING PROCESS IN THE FABRICATION PROCESS OF THE SPRING MATERIAL AND OVER TIME THE RETAINING RING LOST ENOUGH OF ITS SPRING-TENSION AND IT ULTIMATELY WORKED ITSELF OUT OF THE GROOVE. WE DID A VISUAL INSPECTION OF THE RETAINING RING IN STOCK AND ALL APPEARED TO BE CONSISTENT IN COLOR. WE ALSO SAMPLED THE SPRING-TENSION ON 20 RETAINING RINGS AND ALL APPEARED TO BE CONSISTENT IN SPRING-TENSION.

    Description of Event or Problem · 1

    ON FEBRUARY 5TH, IT WAS REPORTED TO MEDICAL ILLUMINATION THAT A MI-1000 LIGHT HEAD HAD SEPARATED FROM THE YOKE. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305204 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTRNATION INC. 061524 00816835020164

    Patients

    Seq Age Sex Outcome Treatment
    1