BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS

    MDR report key: 19665868 · Received July 3, 2024

    Report

    Report Number
    19665868
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 11, 2024
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE 10MM NEXUS BONESCALPEL TUBING (REF #110-31-1110 LOT #233150) STARTED TO LEAK AS SOON AS THE BAG WAS SPIKED. THE LEAK IS COMING FROM RIGHT WHERE THE BAG IS SPIKED. A TEGADERM WAS PLACED AROUND THE TUBING TO MAKE SURE IT STOPPED DURING THE CASE. MANUFACTURER RESPONSE FOR INSTRUMENT, ULTRASONIC SURGICAL, NEXUS (PER SITE REPORTER). NO RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800378 NEXUS INSTRUMENT, ULTRASONIC SURGICAL LFL MISONIX, INC. 110-31-1110 233150

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female