BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT

    MDR report key: 6954213 · Received October 17, 2017

    Report

    Report Number
    9681407-2017-00034
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 19, 2017
    Report Date
    September 19, 2017
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS KNOWN THAT AN IMPROPER INSTALLATION, MAINTENANCE OR A COLLISION CAN LEAD TO THE SPRING ARM COVER FALLING OFF. THE DEVICE WAS EVALUATED AND REPAIRED BY A TRUMPF MEDICAL SERVICE TECHNICIAN.

    Description of Event or Problem · 1

    THE FRONT COVER OF A SPRING ARM ON A TRUMPF MEDICAL SURGICAL LIGHT SYSTEM FELL OFF DURING A PROCEDURE AND INTO THE STERILE FIELD. THE COVER DID NOT CONTACT THE PATIENT AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734252 TRULIGHT SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1574759

    Patients

    Seq Age Sex Outcome Treatment
    1