BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT

    MDR report key: 6109242 · Received November 17, 2016

    Report

    Report Number
    9681407-2016-00013
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FQP
    PMA / PMN Number
    K102758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT HEAD IS SECURED BY A RETAINING SEGMENT AT THE SPRING ARM. TO PREVENT THE RETAINING SEGMENT FROM DISLODGING, A SLEEVE COVERS THE RETAINING SEGMENT. WHEN OUR LOCAL PARTNER EVALUATED THE LIGHT IN ORDER TO INVESTIGATE THE INCIDENT, IT WAS FOUND THAT THE SLEEVE IS STAYING IN THE RAISED POSITION, INSTEAD OF COVERING THE RETAINING SEGMENT. THUS, THE LOCKING /RETAINING SEGMENT, NOT COVERED BY THE SLEEVE, AS A RESULT DISLODGED FROM ITS NORMAL POSITION RESULTING THE CARDANIC ARM AND THE SPRING ARM DISCONNECTION. ROOT CAUSE FOR THIS INCIDENT IS DETERMINED TO BE A SCREW THAT WAS NOT COMPLETELY SEATED AFTER A SERVICING EVENT, WHICH PREVENTED THE PROTECTIVE SLEEVE FROM LOWERING THEREFORE ALLOWING THE RETAINING SEGMENT TO DISLODGE. ALL OF THE FACILITY'S OR'S AND THE LIGHTHEADS WERE EVALUATED PER OUR MAINTENANCE CHECK LIST IN THE PRESENCE OF THE HOSPITAL BIOMEDICAL GROUP. THE LIGHTHEAD WILL BE REPLACED DUE TO DAMAGE INCURRED IN THE FALL.

    Description of Event or Problem · 1

    A TRUMPF MEDICAL CEILING MOUNTED SURGICAL LIGHT SEPARATED AT THE CARDANIC - SPRING ARM JOINT AND FELL TO THE FLOOR DURING AN OPERATION. A TRUMPF MEDICAL SERVICE TECHNICIAN FOUND THAT THE RETAINING SLEEVE ON THE SPRING ARM WAS IN THE UPPERMOST POSITION, ALLOWING THE RETAINING SEGMENT TO BACK OUT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760613 TRULIGHT TRULIGHT 5500 FQP TRUMPF MEDIZIN SYSTEME GMBH + CO. KG TRULIGHT 5500

    Patients

    Seq Age Sex Outcome Treatment
    1