BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVADAQ 50L INSUFFLATOR

    MDR report key: 6139831 · Received December 1, 2016

    Report

    Report Number
    3012345110-2016-00001
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    HIF
    PMA / PMN Number
    K120151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NORTHGATE TECHNOLOGIES INC. IS THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) OF THE 50L INSUFFLATOR, WHICH IS THE SUBJECT OF THIS REPORTABLE EVENT. NOVADAQ TECHNOLOGIES INC. IS THE RE-PACKAGER/RE-LABELER OF THIS 50L INSUFFLATOR. NOVADAQ'S NAME AND BRANDING IS PRESENT ON THE INSUFFLATOR'S PACKAGING AND LABELING; THAT IS, THE DEVICE IS LABELED AS THE "NOVADAQ 50L INSUFFLATOR". SINCE THIS DEVICE MALFUNCTION/PRODUCT PROBLEM OCCURRED WITH THE NOVADAQ-BRANDED INSUFFLATOR, NOVADAQ TECHNOLOGIES INC. IS THEREFORE THE PARTY SUBMITTING THIS REPORT.

    Description of Event or Problem · 1

    A 50L INSUFFLATOR (MANUFACTURED BY NORTHGATE TECHNOLOGIES) WAS BEING USED WITH NOVADAQ TUBING AND NOVADAQ PINPOINT SYSTEM FOR AN ENTIRE RT HEMICOLECTOMY CASE. THE MONITOR WAS SET AT HIGH FLOW: 25 AND PRESSURE: 15. ABOUT AN HOUR AND A HALF INTO THE CASE, THE PATIENT'S ABDOMEN BECAME OVER-INFLATED. THE ACTUAL PRESSURE ON THE INSUFFLATOR MONITOR READ 35 AND WAS RISING UP TO 40. THE PATIENT'S CO2 LEVEL WAS RISING PAST 60 WHEN THE PHYSICIAN DECIDED TO END THE LAPAROSCOPIC PORTION OF THE PROCEDURE EARLY DUE TO THE INSUFFLATOR NOT FUNCTIONING PROPERLY. AFTER THE OPEN PORTION OF THE PROCEDURE, THE SURGEON DECIDED TO GO BACK IN LAPAROSCOPICALLY, DESPITE THE CLINICAL REPRESENTATIVE'S RECOMMENDATION TO NOT USE THE INSUFFLATOR AGAIN. THE SURGEON USED THE INSUFFLATOR FOR A TOTAL OF ABOUT 5 MINUTES AND THERE WERE NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790820 NOVADAQ 50L INSUFFLATOR INSUFFLATOR HIF NORTHGATE TECHNOLOGIES INC. 89607DYA

    Patients

    Seq Age Sex Outcome Treatment
    1