BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NOVADAQ_PRODUCT

    MDR report key: 7737482 · Received July 31, 2018

    Report

    Report Number
    3012345110-2018-00005
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    November 2, 2015
    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. INITIAL INVESTIGATION BY NOVADAQ OF THE EVENT SHOWED THAT UNDER NORMAL USE CONDITIONS THE ENDOSCOPE IS NOT CAPABLE OF HEATING THE TROCAR PAST 31°C, WHICH IS BELOW THE IEC 60601-1 § 11.1.2.2 THRESHOLD (¿SURFACE TEMPERATURES OF APPLIED PARTS NOT INTENDED TO SUPPLY HEAT TO THE PATIENT MUST NOT SURPASS 41°C WITHOUT FURTHER CONSIDERATION¿). FURTHER INVESTIGATION BY NOVADAQ REVEALED THAT LAPAROSCOPES AND TROCARS CAN INADVERTENTLY SERVE AS ALTERNATIVE CURRENT PATHS FOR CURRENT TO FLOW BACK TO THE NEUTRAL CONDUCTOR WHEN USING MONOPOLAR ELECTROCAUTERY SYSTEMS. THIS CAN RESULT IN ABNORMAL HEAT ENERGY BEING GENERATED AT THE TROCAR, THUS POTENTIALLY CAUSING PATIENT BURNS. THE PINPOINT OPERATOR'S MANUAL INCLUDES A WARNING TO THE USERS THAT STATES THE FOLLOWING: "NOVADAQ RIGID LAPAROSCOPES ARE NOT DESIGNED TO PROVIDE INSULATION AGAINST HIGH-FREQUENCY (HF) ELECTRICAL CURRENTS. TO PREVENT BURNS AND UNINTENDED THERMAL INJURY OF SURROUNDING TISSUE, ACTIVATE ELECTRODES ONLY WHEN VISIBLE THROUGH THE LAPAROSCOPE AND AVOID CONTACT BETWEEN ACTIVE ELECTRODES AND THE LAPAROSCOPE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE COMPLETION OF THE PROCEDURE, A BURN WAS OBSERVED ON THE SKIN AROUND THE PORT. THE NOVADAQ PRODUCT REPORTED IN THE EVENT, THE LAPAROSCOPE, MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE BURN. THE BURN WAS THE RESULT OF A METAL TROCAR, NOT MANUFACTURED BY NOVADAQ, HEATING DURING THE PROCEDURE AND INJURING THE SURROUNDING TISSUE. THE LAPAROSCOPE MAY HAVE AIDED IN THE HEAT TRANSFER FROM EXTENDED TIME IN NIR ILLUMINATION. IT WAS REPORTED THE SURGEON DID NOT BELIEVE THE BURN WAS SERIOUS, HOWEVER IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576821 UNKNOWN_NOVADAQ_PRODUCT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ NOVADAQ TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other