BEUDAMED
    FDA Adverse Event Other Summary report: N

    9710055-2007-00014

    MDR report key: 975061 · Received July 20, 2007

    Report

    Report Number
    9710055-2007-00014
    Event Type
    Other
    Date Received
    July 20, 2007
    Product Code
    FSY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT PROBLEM IS LIMITED TO X'TEN SURGICAL LIGHT SYSTEMS WITH SINGLE FORK, VIDEO FEATURE. REVIEW AND IMPROVEMENTS TO PROCESSES AT THE SUPPLIER OF THE SPRING ARM WERE IMPLEMENTED. MFR DETERMINED THAT THE CRIMPING TOOL USED BY THEIR SUPPLIER WAS NOT ALLOWING GOOD POSITIONING OF THE HOOKS (TO LOCK THE PINS INSIDE THE CONNECTOR HOUSING). AS A RESULT SOME OF THE PINS MOVE BACKWARD DURING INSTALLATION. WHEN THE PINS MOVE BACKWARD THE ELECTRICAL CONTACT WILL NOT BE EFFICIENT ANYMORE, THE CONNECTOR WILL OVERHEAT AND MELT, AND THE CONNECTION CAN BE LOST. NOTICEABLE DIMMING OF THE LIGHT OUTPUT CAN RESULT. THE LIGHT ARMS ARE BEING REPLACED. MAQUET SA PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FSY

    Patients

    Seq Age Sex Outcome Treatment
    1