BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILED DUO TUSM

    MDR report key: 8739180 · Received June 27, 2019

    Report

    Report Number
    9681407-2019-00017
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    May 31, 2019
    Report Date
    May 31, 2019
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE SURGICAL LIGHT SYSTEM AND FOUND THAT THE SNAP RING WAS NOT IN ITS PROPER PLACE. THE SPRING ARM 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SPRING ARM WAS LOOSE ON A TRUMPF MEDICAL SURGICAL LIGHT SYSTEM. AN INSPECTION OF THE DEVICE REVEALED THAT THE SNAP RING WAS NOT IN ITS PROPER PLACE, ALLOWING THE SPRING ARM TO SLIDE OUT OF PLACE FROM ITS CONNECTION POINT TO THE CENTER AXIS. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535946 ILED DUO TUSM SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1565160

    Patients

    Seq Age Sex Outcome Treatment
    1