BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMOS

    MDR report key: 19839863 · Received July 26, 2024

    Report

    Report Number
    3006437518-2024-00011
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    July 5, 2024
    Report Date
    September 27, 2024
    Manufacturer
    DKK DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FSY
    PMA / PMN Number
    K071698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN USING THE LUMOS WITH THE IOBAN 2 DRAPE(3M), THE SURGEON NOTICED THAT THE IOBAN 2 DRAPE MELTED ONTO THE PATIENT CAUSING A BURN. THE LUMOS PRODUCED HIGHT TEMPERATURES, SUCH THAT ITS OPERATION IS COMPROMISED OR HARM IS CAUSED (OVERHEATING THAT PRODUCES MELTING OF COMPONENTS OR AUTOMATIC SHUTDOWN).

    Description of Event or Problem · 0

    WHEN USING THE LUMOS WITH THE IOBAN 2 DRAPE (3M), THE SURGEON NOTICED THAT THE IOBAN 2 DRAPE MELTED ONTO THE PATIENT CAUSING A BURN. THE LUMOS PRODUCED HIGHT TEMPERATURES, SUCH THAT ITS OPERATION IS COMPROMISED OR HARM IS CAUSED (OVERHEATING THAT PRODUCES MELTING OF COMPONENTS OR AUTOMATIC SHUTDOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777127 LUMOS CAMERA, SURGICAL, CEILING MOUNTED, PRODUCT CODE: FSY FSY DKK DAI-ICHI SHOMEI CO., LTD. LUMOS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization