BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT DUO TUSM

    MDR report key: 9210687 · Received October 18, 2019

    Report

    Report Number
    9681407-2019-00044
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    October 4, 2019
    Report Date
    October 4, 2019
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE SURGICAL LIGHT SYSTEM AND FOUND THE SPRING ARM PARTIALLY DISLODGED FROM THE CENTER AXIS ARM. 1 WASHER WAS REMOVED, THE SNAP RING WAS REPLACED, AND THE LIGHT FUNCTIONED AS DESIGNED. A FIELD CORRECTIVE ACTION HAS BEEN INITIATED BY TRUMPF MEDICAL AND REPORTED TO THE FDA AS A RESULT OF INVESTIGATIONS INTO SIMILAR EVENTS (RECALL NUMBER Z-563-2016). THE INVESTIGATIONS HAVE FOUND THAT IMPROPER INSTALLATION OR SERVICING OF THE CIRCLIP IN THIS JOINT CAN RESULT IN THE SLIPPING DOWN OR FALLING OF THE SPRING ARM AND LIGHT HEAD COMPONENTS. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SPRING ARM WAS COMING LOOSE ON A TRUMPF MEDICAL SURGICAL LIGHT SYSTEM. AN INSPECTION OF THE DEVICE REVEALED THE IMPROPER INSTALL OF 2 WASHERS BELOW THE SNAP RING, WHERE THERE SHOULD ONLY BE 1. THE ADDITIONAL WASHER HINDERED THE SNAP RING FROM SECURING THE SPRING ARM IN PLACE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001396 TRULIGHT DUO TUSM SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1574850

    Patients

    Seq Age Sex Outcome Treatment
    1