BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF ILED 5K

    MDR report key: 3222067 · Received July 8, 2013

    Report

    Report Number
    9681407-2013-00001
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 26, 2013
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF REP ARRIVED AT THE USER FACILITY AND FOUND THAT 2 OF 3 LOCKING PINS WERE MISSING FROM THE ATTACHING POINT ON THE LAMP HEAD. THE DEVICE WAS THEREFORE OUT OF SPECIFICATION WHEN THE MALFUNCTION OCCURRED. A COMPLETE CONNECTION ASSEMBLY WAS SENT AND REPLACED ON THIS LAMP. THE COMPONENTS THAT WERE REPLACED ON THE DEVICE WERE EVALUATED BY THE IMPORTER, TRUMPF MEDICAL SYSTEMS, INC. THE PINS WERE MISSING, BUT IT IS UNK AT THIS TIME HOW THE DEVICE BECAME OUT OF SPECIFICATION. ADDITIONALLY, THE ROTATING PLATE EDGE WAS DEFORMED, MOST LIKELY DUE TO THE DEVICE BEING USED WITH ONLY 1 OF 3 LOCKING PINS IN PLACE.

    Description of Event or Problem · 1

    SURGICAL LIGHT "DUMMY" CAMERA HANDLE WEIGHT BECAME UNATTACHED FROM A LIGHT AND FELL. THE INCIDENT OCCURRED DURING PREPARATION FOR A CASE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308887 TRUMPF ILED 5K TRUMPF ILED 5K FSY TRUMPF MEDIZIN SYSTEME GMBH ILED 5K

    Patients

    Seq Age Sex Outcome Treatment
    1