BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NOVADAQ_PRODUCT

    MDR report key: 7737491 · Received July 31, 2018

    Report

    Report Number
    3012345110-2018-00007
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 1, 2017
    Report Date
    July 31, 2018
    Manufacturer
    NOVADAQ TECHNOLOGIES
    Product Code
    GCJ
    PMA / PMN Number
    K150956
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVADAQ TECHNOLOGIES, INC. WAS ACQUIRED BY STRYKER. THIS MDR IS BEING SUBMITTED LATE BECAUSE IT WAS IDENTIFIED DURING THE INTEGRATION AND REMEDIATION ACTIVITIES INITIATED BY STRYKER ENDOSCOPY IN CONJUNCTION WITH THIS ACQUISITION. PREVIOUS INVESTIGATION BY NOVADAQ SHOWED THAT CONTAMINATION OF THE CONNECTION BETWEEN THE LIGHT GUIDE AND THE LAPAROSCOPE AT THE LIGHT GUIDE POST MAY RESULT IN HEATING OF THE LIGHT GUIDE POST. SUCH CONTAMINATION MAY OCCUR EITHER DUE TO INCOMPLETE CLEANING OF THE LIGHT GUIDE, OR AS A RESULT OF HANDLING OF THE LIGHT GUIDE PRIOR TO CONNECTION WITH THE LAPAROSCOPE. THE RESULTS OF THIS TEST SHOWED THAT ONLY THE LIGHT GUIDE POST OF THE LAPAROSCOPE, AND TO A LESSER EXTENT THE BODY OF THE LAPAROSCOPE, HEAT SIGNIFICANTLY DUE TO CONTAMINATION; ALL OTHER PORTIONS OF THE LIGHT GUIDE REMAIN AT OR BELOW THE TEMPERATURE AT THE SAME LOCATION WHEN NO CONTAMINATION IS PRESENT. TESTING ALSO SHOWED THAT THE MAXIMUM TEMPERATURE REACHED BY THE LIGHT GUIDE POST IS 54C WHEN REASONABLE LEVELS OF CONTAMINATION ARE PRESENT. NOTE, THE TEMPERATURE REQUIRED FOR THE SAFETY OF ELECTROMEDICAL DEVICES IN AREAS LIKELY TO BE TOUCHED FOR 10S OR LESS IS 56 C FOR METALS PARTS PER IEC 60601-1:2012 §11.1.1. THE DEVICE MANUFACTURER DATE IS NOT KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT GUIDE HEATED UP AND BURNED THE SURGEON WHEN HE SWITCHED SCOPES. THE SEVERITY OF THE INCIDENT NOR THE REQUIRED INTERVENTION TO TREAT THE BURN, IF ANY, WAS NOT ABLE TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576823 UNKNOWN_NOVADAQ_PRODUCT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ NOVADAQ TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    0 Other