BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVADAQ 50L INSUFFLATOR

    MDR report key: 6198989 · Received December 22, 2016

    Report

    Report Number
    3012345110-2016-00002
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 21, 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 REPACKAGER/RELABELER 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

    DURING A SURGICAL PROCEDURE THE INSUFFLATOR STOPPED INFLATING EVERY FEW MINUTES AND THE SURGEON WAS HAVING ISSUES WITH CONTROLLING BLEEDING. IT WAS DETERMINED THAT THE ISSUE WAS WITH THE SHUTTLE VALVE. THERE WAS A MINOR LEAK WHICH WAS CAUSING THE MONITOR NOT TO BE ABLE TO GAUGE THE GAS LEVELS, AND DUE TO THAT, THE MONITOR WOULD SHUT OFF DUE TO THINKING THERE WAS NO GAS. THE ISSUE HAS NOW BEEN RESOLVED AND EVERYTHING IS FUNCTIONING PROPERLY. THIS PRODUCT PROBLEM HAS NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849659 NOVADAQ 50L INSUFFLATOR INSUFFLATOR HIF NORTHGATE TECHNOLOGIES INC. 11727

    Patients

    Seq Age Sex Outcome Treatment
    1