BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEBULAE® SRS LAPAROSCOPIC SURGICAL SMOKE REMOVAL PUMP

    MDR report key: 19287395 · Received May 10, 2024

    Report

    Report Number
    0001450997-2024-00005
    Event Type
    Death
    Date Received
    May 10, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 10, 2024
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    GCX
    UDI-DI
    00817183020684
    PMA / PMN Number
    NTI K202944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO PRODUCT MALFUNCTION REPORTED OR SUSPECTED IN THE PROCEDURE THAT PRECEDED THIS EVENT. THE DEVICE HISTORY RECORD FOR 200071MDGE FROM APRIL OF 2022 (MO 15801) WAS REVIEWED AND THERE WAS NOTHING NOTED IN THE DEVICE HISTORY RECORD THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE POST-OP DEATH. AS INDICATED IN THE COMPLAINT DESCRIPTION BY THE INITIAL COMPLAINANT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO KNOW MALFUNCTION OR COMPLICATION DURING THE PROCEDURE EXECUTION. THE CAUSE OF DEATH IS UNKNOWN BY THE MANUFACTURER, HOWEVER LAPAROSCOPIC SURGERIES (HYSTERECTOMIES) DO HAVE RISKS ASSOCIATED WITH THEM. THE NOR-DOC-DRA-0034 RISK ANALYSIS WAS REVIEWED. RISK ID 7.8.1.10 (PRESSURE) AND 7.8.2.1 (INFECTION) ARE THE TWO LINE ITEMS THAT COULD RESULT IN A RISK OF DEATH. IT WAS NOT STATED THAT THE PATIENT ABDOMEN EXPERIENCED ANY INCREASED PRESSURE EVENTS DURING THE SURGERY, AND IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY INFECTIONS POST PROCEDURE. THE RISKS ARE MITIGATED THROUGH DESIGN AND TESTING TO INSURE THE TUBING IS ADEQUATELY DESIGNED TO PREVENT THE INTRODUCTION OF ROOM AIR AND THE MANUAL CONTAINS CLEAR INSTRUCTION AND WARNING REGARDING THE USE OF ACCESSORIES AND INSPECTION OF THE TUBING SETS PRIOR TO USE FOR DAMAGE. THE RISKS ASSOCIATED WITH THE USE OF THE DEVICE LEADING TO DEATH IS CONSIDERED LESS THAN REMOTE. IF FURTHER INFORMATION WAS TO BECOME AVAILABLE OR PRODUCT RETURNED FROM THE FIELD FOR FURTHER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED AT THAT TIME. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT AND POST MARKET SURVEILLANCE SYSTEMS TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    ON 04/10/2024 NTI WAS INFORMED THAT THERE WAS A PATIENT DEATH AFTER A CASE THAT INVOLVED THE USE OF NEBULAE SRS. THERE WAS NO NEBULAE SRS COMPLAINT TO REPORT FROM THIS SURGERY. THE SUBJECT DIED POST-OP FOLLOWING A ROBOTIC HYSTERECTOMY. CITY OF HOPE IS CONDUCTING AN AUTOPSY TO DETERMINE THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920864 NEBULAE® SRS LAPAROSCOPIC SURGICAL SMOKE REMOVAL PUMP SURGICAL PLUME EVACUATION SYSTEM GCX NORTHGATE TECHNOLOGIES INC. 7-700-00 00817183020684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death