BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT DUO

    MDR report key: 7699823 · Received July 18, 2018

    Report

    Report Number
    9681407-2018-00034
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 22, 2018
    Report Date
    June 22, 2018
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN WAS DISPATCHED TO INSPECT THE LIGHT SYSTEM AND FOUND THAT THE STERILE HANDLE ADAPTER PLATE WAS INSTALLED IMPROPERLY BY ONE OF THE FACILITY'S 3RD PARTY VENDORS AFTER INSTALLATION. THE ADAPTER WAS PROPERLY REINSTALLED AND THE DEVICE FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540717 TRULIGHT DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 4038210

    Patients

    Seq Age Sex Outcome Treatment
    1