BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED TRIO

    MDR report key: 7134659 · Received December 20, 2017

    Report

    Report Number
    9681407-2017-00043
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 20, 2017
    Report Date
    November 20, 2017
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE LIGHT SYSTEM AND FOUND THE PRODUCT TO BE OPERATING WITHIN SPECIFICATION. THE TRUMPF MEDICAL QA/RA MANAGER VISITED THE SITE TO FURTHER INVESTIGATE THE INCIDENT. INTERVIEWS WITH HOSPITAL STAFF REVEALED THAT LIGHT PATTERNS FROM MULTIPLE LAMP HEADS WERE OVERLAPPED. THE USER MANUAL FOR THE ILED 7 LIGHTING SYSTEM STATES: "VISIBLE LIGHT GENERATES HEAT IN THE OPERATING AREA, DUE TO PHYSICAL EFFECTS. HIGH IRRADIATION DENSITIES ARE GENERATED WHEN THE LIGHT FIELDS OF SEVERAL LIGHT HEADS OVERLAP. THIS CAN CAUSE DRYING OF TISSUE AND, PARTICULARLY AFTER PROLONGED EXPOSURE, REDUCED PERFUSION AND TISSUE DAMAGE. THE LIGHT INTENSITY MUST BE REDUCED WHEN PERFUSION IS REDUCED OR THE TISSUE STARTS TO DRY OUT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED ALLEGED TISSUE DAMAGE A DAY OR TWO AFTER A SURGICAL PROCEDURE IN WHICH TRUMPF MEDICAL SURGICAL LIGHTS WERE USED. THE PATIENT RECEIVED MEDICAL ATTENTION TO TREAT THE TISSUE DAMAGE; HOWEVER, THE USER FACILITY DID NOT PROVIDE THE DETAILS OF THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914257 ILED TRIO ILED 7 FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG I771

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention