BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT HEAD D 660 AC

    MDR report key: 5240770 · Received November 20, 2015

    Report

    Report Number
    0001220865-2015-00007
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 27, 2015
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE LIGHT ALLEGEDLY BURNED A CHILD DURING SURGERY. THROUGH INVESTIGATION BY A STRYKER FIELD SERVICE TECHNICIAN AND A QUALITY ENGINEER, IT WAS DETERMINED THAT THE LIGHTS WERE ALL FOCUSED ON THE SURGICAL SITE. THE DISTANCE OF THE LIGHTS FROM THE PATIENT WERE MEASURED. THE USER MANUAL PROVIDED TO THE CUSTOMER WARNS "THE OVERLAY OF THE LIGHT FIELDS CAN CAUSE AN INCREASES IN HEAT GENERATION". THE TECHNICIAN INSPECTED THE THREE LIGHTS IN THE OPERATING ROOM WHERE THE ALLEGED BURN OCCURRED. THE LUX LIGHT READING AND VOLTAGE MEASUREMENT FOR ALL THREE LIGHTS WERE RECORDED. ADDITIONAL INVESTIGATION IS STILL ONGOING AND A SUPPLEMENTAL MDR WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED, IF NEW INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE LIGHT ALLEGEDLY MAY HAVE BEEN THE SOURCE OF A BURN ON A CHILD. DUE TO THE ALLEGED INJURY FROM THE LIGHTS, STRYKER INVESTIGATED AND FILED A MDR. THE PRODUCT WAS NOT RETURNED. THE LIGHT WAS EXAMINED ON SITE IN THE OPERATING ROOM. THERE WAS MINIMAL PHYSICAL DAMAGE BASED ON VISUAL INSPECTION. THERE WAS EVIDENCE THAT THE 3 LIGHT HEADS IN THE OR WERE POSITIONED IN A WAY THAT THE LIGHT FIELDS OVERLAPPED DURING THE PROCEDURE. THE DHR WAS REVIEWED. THE LIGHT WAS MANUFACTURED TO SPECIFICATION. STRYKER CONCLUDES THAT THIS WAS A RESULT OF IMPROPER USE OF DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT ALLEGEDLY MAY HAVE BEEN THE SOURCE OF A BURN ON A CHILD. DUE TO THE ALLEGED INJURY FROM THE LIGHTS, STRYKER WILL INVESTIGATE AND FILE A MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT ALLEGEDLY MAY HAVE BEEN THE SOURCE OF A BURN ON A CHILD. DUE TO THE ALLEGED INJURY FROM THE LIGHTS, STRYKER WILL INVESTIGATE AND FILE A MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768817 LIGHT HEAD D 660 AC CHROMOPHARE D SERIES FSY BERCHTOLD CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other