BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED DUO

    MDR report key: 8461958 · Received March 28, 2019

    Report

    Report Number
    9681407-2019-00007
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    February 28, 2019
    Report Date
    February 28, 2019
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE ILED DUO SURGICAL LIGHT SYSTEM AND FOUND THAT THE CIRCLIP WAS NOT IN ITS PROPER PLACE, ALLOWING THE SPRING ARM TO SLIDE OUT OF PLACE FROM ITS CONNECTION POINT TO THE CENTER AXIS. THE CIRCLIP WAS REPLACED PROPERLY AND THE LIGHT FUNCTIONED AS INTENDED. 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.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A LAMP HEAD OF A TRUMPF MEDICAL SURGICAL LIGHT SYSTEM WOULD NOT POWER ON. AN INSPECTION OF THE DEVICE REVEALED A GAP WAS PRESENT BETWEEN THE SPRING ARM AND THE CENTRAL AXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253352 ILED DUO SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1357782

    Patients

    Seq Age Sex Outcome Treatment
    1