BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRULIGHT

    MDR report key: 5190233 · Received October 30, 2015

    Report

    Report Number
    9681407-2015-00012
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    FSY
    PMA / PMN Number
    K061317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) REPORTED TO TRUMPF MEDICAL SYSTEMS ON (B)(6) 2015 THAT A PIECE FELL FROM A TRULIGHT SPRING ARM ELBOW DURING A CASE INTO THE STERILE FIELD. NO INJURY WAS REPORTED. REPLACEMENT PARTS WERE SHIPPED TO THE ACCOUNT AND HAVE BEEN INSTALLED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DURING THE POSITIONING OF THE LIGHT HEAD, A PLASTIC PART OF THE SPRING ARM JOINT COVER FELL INTO THE STERILE AREA. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722937 TRULIGHT CEILING MOUNTED SURGICAL LIGHT FSY TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1574850

    Patients

    Seq Age Sex Outcome Treatment
    1