BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MI-1000

    MDR report key: 4943575 · Received July 22, 2015

    Report

    Report Number
    2028295-2015-00002
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    March 27, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Product Code
    FST
    PMA / PMN Number
    K100388
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL ILLUMINATION EXAMINED THE SUPPLIED PHOTOGRAPHS AND IT WAS APPARENT THAT THE LIGHT WAS NOT INSTALLED PER THE INSTRUCTIONS. WHEN PROPERLY INSTALLED, THE PIN IS INSERTED THROUGH A HOLE IN THE CEILING ROD AND THIS PIN SITS IN A RECESS IN THE MOUNTING CASTING. THE PIN, WHICH SUPPORTS THE WEIGHT OF THE LIGHT FIXTURE IS PREVENTED FROM MOVING BY THE WALLS OF THE RECESS. THE PHOTOS SHOWED THAT THE ROD WAS INSTALLED TOO HIGH IN THE CEILING CASTING WITH ONLY THE SET-SCREW HOLDING THE ROD IN PLACE AND THE PIN NOT PROPERLY SEATED. THIS WAS EVIDENT IN THAT THE SCARRING ON THE PAINTED SURFACE INDICATED THAT THE ROD WAS NOT PROPERLY SEATED IN THE CASTING WHICH ALLOWED THE ROD TO "WOBBLE" GIVING A PATHWAY FOR THE PIN TO WORK ITS WAY OUT OF THE ROD. THE INSTALLATION OF THE LIGHT WAS DEEMED TO BE IN ERROR AND IT WAS COMMUNICATED TO DR. (B)(6) VIA EMAIL ON (B)(6) 2015. FURTHER INVESTIGATION ALSO INDICATED THAT THE INITIAL REPORT THAT THE LIGHT HIT THE SCRUB NURSE AND PATIENT WAS ERRONEOUS BY THE DOCTOR WHO PERFORMED THE PROCEDURE THAT THE LIGHT DID NOT HIT THE DOCTOR, STAFF OR PATIENT. THE FINAL COMMUNICATION IN THIS CASE WAS THE DOCTOR WANTED THE LIGHT REINSTALLED AS SOON AS POSSIBLE. THIS CASE WAS CLOSED ON (B)(4) 2015.

    Description of Event or Problem · 1

    ON (B)(6) 2015 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING AN MI-1000 LIGHT FALLING DURING A PROCEDURE ON (B)(6) 2015. THE INITIAL REPORT STATED THAT THE DOWEL PIN BROKE AND THE LIGHT FELL AND HIT THE DOCTOR, THE SCRUB NURSE AND THE PATIENT BUT NO OTHER DETAILS WERE GIVEN. PICTURES WERE ALSO SUPPLIED OF THE SUSPECTED FAILED COMPONENT, THE MOUNTING ROD DOWEL PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477161 MI-1000 MINOR SURGICAL LIGHT FST MEDICAL ILLUMINATION INTERNATIONAL, INC. 061514

    Patients

    Seq Age Sex Outcome Treatment
    1