BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL LIGHT, CEILING MOUNTED

    MDR report key: 23345169 · Received October 21, 2025

    Report

    Report Number
    3006437518-2025-00002
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 21, 2025
    Manufacturer
    DKK DAI-ICHI SHOMEI
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON THE (B)(6) 2025, DKK WAS INFORMED BY THE INITIAL IMPORTER THAT THE DKK DEVICE MIGHT HAVE CAUSED A BURN DURING THE SURGERY. DKK IS REACHING OUT TO THE IMPORTER TO TRY AND GATHER INFORMATION REGARDING ANY INJURIES AND HOW THE LIGHT WAS USED, AS CURRENTLY NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ON THE 4TH NOVEMBER, DKK RECEIVED ADDITIONAL INFORMATION FROM THE IMPORTER. THE INFORMATION IS WHAT THE IMPORTER RECEIVED FROM THE FACILITY WITH DETAILS AS BELOW: PATIENT WAS BROUGHT TO OR #10 FOR AN EXPLORATORY LAPAROTOMY AND RIGHT INGUINAL HERNIA REPAIR. PATIENT'S ABDOMEN PREPPED AND SURGICAL DRAPES APPLIED. WHILE GAINING ACCESS TO THE ABDOMEN, SURGEON AND ANESTHESIOLOGIST NOTED INCREASED TEMPERATURE ON THE PATIENT'S ABDOMEN AND TURNED OFF OR SPOTLIGHTS THAT ARE CONNECTED TO THE SKYTRONS BOOMS. AFTER THE LAPAROSCOPIC PORTION OF THE PROCEDURE, OR SPOTLIGHTS WERE TURNED BACK ON. AFTER THE PROCEDURE ENDED AND DRAPES WERE REMOVED, A DARKENED AREA OF SKIN IN THE SHAPE OF THE DRAPED AREA WAS NOTED ON THE PATIENT'S ABDOMEN. COLD PACKS WERE IMMEDIATELY RETRIEVED AND PLACED ON THE ABDOMEN. THIS EVENT CORRESPONDS WITH PREVIOUS REPORTED CONCERNS RELATED TO THE OR LIGHTING IN THIS PARTICULAR OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451748 SURGICAL LIGHT, CEILING MOUNTED FSY DKK DAI-ICHI SHOMEI

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Other