BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    INSUFFLATOR TUBING SET

    MDR report key: 17582953 · Received August 21, 2023

    Report

    Report Number
    3010437008-2023-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    January 8, 2019
    Report Date
    June 30, 2023
    Manufacturer
    ADVANCED MEDICAL DESIGN CO., LTD.
    Product Code
    NKC
    UDI-DI
    04711605992114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    IN GENERAL, THE AIR FLOW RATE OF INSUFFLATION TUBING SET WOULD BE 20 L/MIN DURING THE CLINICAL SITUATION. THEREFORE, WE SET A PRESSURE OF AIR OUTPUT AS 20 L/MIN AND THEN APPLY TO RETURNED SAMPLE TO SEE WHETHER OCCLUSION HAPPENS. THE INTENDED USE OF INSUFFLATION TUBING SET IS TO FILTER AND DELIVER INSUFFLATION GAS (CO2) FROM AN INSUFFLATION PUMP TO AN INSUFFLATION NEEDLE OR SUITABLE LAPAROSCOPIC PORT AS A MEANS TO PROVIDE PERITONEAL INSUFFLATION AND ALLOW FOR THE MANIPULATION OF INSTRUMENTS DURING LAPAROSCOPIC PROCEDURES. AND THE DESCRIPTION OF THE COMPLAINT MENTIONED THAT THE DEVICE WAS OCCLUDED. HOWEVER, AFTER INVESTIGATING THE RETURNED SAMPLE, IT WAS QUIET GOOD TO PROVIDE THE FUNCTION OF INTENDED USE AND REACH THE RATE OF CLINICAL REQUIREMENT. THE MALFUNCTION WAS NOT FOUND, BESIDES, THERE WAS NO FURTHER INFORMATION OR SCENARIOS DURING THE USE GAVE TO AMD. SUMMARY ACCORDING TO INVESTIGATION ABOVE, THE FUNCTION OF INSUFFLATION TUBING SET IS GOOD AND PROVIDE WHAT IT SHOULD DO FOR CLINICAL REQUIREMENT.

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: DURING USE THE INSUFFLATION TUBING OCCIUDED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LAP APPY. WHAT PROBLEM DLD THE USER HAVE? DEVICE MALFUNCTION THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982589 INSUFFLATOR TUBING SET INSUFFLATOR TUBING NKC ADVANCED MEDICAL DESIGN CO., LTD. TM6000 1927955 04711605992114

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male