BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVADAQ 50L INSUFFLATOR

    MDR report key: 6662496 · Received June 22, 2017

    Report

    Report Number
    3012345110-2017-00002
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 23, 2017
    Report Date
    June 22, 2017
    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. (B)(6). IS THE REPACKAGER/RELABELER OF THIS 50L INSUFFLATOR. (B)(6) 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, (B)(6). IS THEREFORE THE PARTY SUBMITTING THIS REPORT.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC COLON RESECTION PROCEDURE USING THE 50 L INSUFFLATOR (MANUFACTURED BY NORTHGATE TECHNOLOGIES), ABOUT AN HOUR INTO THE PROCEDURE THE ABDOMINAL PRESSURE INCREASED FROM 15 TO 36. THE PRESSURE SETTING WAS RESET AND THE CASE PROCEEDED, BUT 5 MINUTES LATER IT INCREASED TO 50. AT THAT POINT THE SURGEON SWITCHED TO A DIFFERENT INSUFFLATOR DUE TO SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442753 NOVADAQ 50L INSUFFLATOR INSUFFLATOR HIF NORTHGATE TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1