BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSNOE MEDICAL INC

    MDR report key: 19654380 · Received July 2, 2024

    Report

    Report Number
    19654380
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 2, 2024
    Manufacturer
    JOSNOE MEDICAL, INC.
    Product Code
    NWV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING LAPAROSCOPIC SURGERY, THERE WERE "WHITE PARTICLES" VISUALIZED IN THE ABDOMINAL AREA, AND UPON PROBLEM SOLVING IT WAS NOTED THAT THE SCOPE WARMER HAD "LIQUID" COMING OUT OF IT (BROKE OPEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759723 JOSNOE MEDICAL INC LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC NWV JOSNOE MEDICAL, INC. PS-500 2111026

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male