BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 4784910 · Received May 15, 2015

    Report

    Report Number
    1825014-2015-00028
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 15, 2015
    Manufacturer
    DAI-ICHI
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A NURSE WAS MANEUVERING THE MICROSCOPE TO POSITION IT FOR THE PROCEDURE WHEN THE TOP COVER OF A SURGICAL LIGHT FELL OFF OF THE FIXTURE WHILE THE PT WAS ON THE SURGICAL TABLE. THE NURSE DID NOT WITNESS THE COVER FALL BUT ONLY HEARD IT HIT THE FLOOR. NO SIGNIFICANT INJURIES WERE SUSTAINED AT THE TIME OF THE INCIDENT. THE FACILITY DID NOTE THAT THE PT HAD MINOR SCRATCHES ON HER NECK. THE LIGHT WAS FACING UPWARD TOWARDS THE CEILING. THE NURSE INTERVIEWED INDICATED THAT THE MICROSCOPE MAY HAVE BEEN SUPPORTING IT. A PREVENTATIVE MAINTENANCE WAS PERFORMED ON THIS LIGHT IN (B)(6) 2014. AT THIS TIME, IT WAS NOTED THAT THE BOLTS THAT HOLD THE TOP COVER ONTO THE LIGHT NEEDED TO BE REPLACED. THE BOLTS WERE ORDERED AND REPLACED BY A CERTIFIED TECHNICIAN. ANOTHER PREVENTATIVE MAINTENANCE WAS PERFORMED IN (B)(4) 2015 AND THE LIGHT WAS FOUND TO BE IN GOOD WORKING CONDITION. AT THIS TIME, THE FACILITY IS NOT RELEASING THE LIGHT FOR FURTHER EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318267 SKYTRON SURGICAL LIGHT FSY DAI-ICHI ST23LH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other