BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT DUO

    MDR report key: 7152050 · Received December 28, 2017

    Report

    Report Number
    9681407-2017-00045
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN WAS DISPATCHED TO INSPECT THE LIGHT SYSTEM AND FOUND NO EVIDENCE OF DAMAGE TO THE HANDLE. THE LIGHT HANDLE COVER WAS REPLACED AND THE LIGHT FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    THE END CAP OF A TRUMPF MEDICAL SURGICAL LIGHT HANDLE FELL INTO THE STERILE FIELD DURING SURGERY. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932740 TRULIGHT DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4038210

    Patients

    Seq Age Sex Outcome Treatment
    1