BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIGHT

    MDR report key: 7082697 · Received December 5, 2017

    Report

    Report Number
    9681407-2017-00040
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 7, 2017
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K102758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF ILED 3 SURGICAL LIGHT INSTALLED BY A (B)(4) DISTRIBUTOR FELL FROM THE CENTRAL AXIS. 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 FIELD ACTION INSPECTION WAS COMPLETED IN JULY 2016 BY THE (B)(4) DISTRIBUTOR. THE LIGHT SYSTEM WAS LATER RECONFIGURED, AT THE REQUEST OF THE CUSTOMER, BY THE (B)(4) DISTRIBUTOR IN AUGUST OF 2017. ANALYSIS OF THE CENTRAL AXIS AND SPRING ARM MOUNTING COLLAR HARDWARE SHOWED THE SNAP RING BECAME DISLODGED AFTER THE SYSTEM WAS RECONFIGURED BY THE (B)(4) DISTRIBUTOR. THE INVESTIGATIONS FOUND THAT IMPROPER INSTALLATION OR SERVICING OF THE SNAP RING IN THIS JOINT CAN RESULT IN THE SLIPPING DOWN OR FALLING OF THE SPRING ARM AND LIGHT HEAD COMPONENTS. THE USER FACILITY WAS SENT THE INITIAL FIELD SAFETY NOTICE LETTER ON JANUARY 14, 2016, WHICH INFORMS USERS OF THE RISK AND ADVISES THAT VISUAL INSPECTIONS BE COMPLETED PRIOR TO EACH USE. THE FIELD ACTION ACTIVITIES INCLUDING INSPECTION AND ADDITIONAL LABELING ARE ONGOING. (B)(4) CONFIRMED THAT THE ACCOUNT SIGNED FOR THE DELIVERY OF THE NOTICE AND RETURNED A CONFIRMATION OF RECEIPT STATING THAT THEY WERE AWARE OF THE POTENTIAL ISSUE 2/5/2016.

    Description of Event or Problem · 1

    SURGICAL STAFF WAS POSITIONING THE LAMP HEAD AND THE ARM FELL FROM THE CENTRAL AXIS. THE STAFF MEMBER WAS ABLE TO CONTROL THE LAMP HEAD, SO THAT IT DID NOT CONTACT THE PATIENT OR OTHER STAFF . AS A RESULT, THE STAFF MEMBER SUFFERED A SPRAINED LIGAMENT IN THE SHOULDER AND REPORTED BACK AND SHOULDER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864120 TRULIGHT ILED 3 LIGHT, SURGICAL, CEILING MOUNTED FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG ILED 3 DUO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other