BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ

    MDR report key: 21513768 · Received March 4, 2025

    Report

    Report Number
    21513768
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 10, 2025
    Manufacturer
    NURSE ASSIST, LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPON STARTING TO USE THE MONOPOLAR DEVICE FROM THE LAPAROSCOPIC TRAY WITH THE CORD FROM THE TRAY, THE CORD BLEW OFF THE DEVICE AND A SPARK OCCURRED. THE CORD WAS REPLACED WITH A DIFFERENT STERILIZED CORD AND NO FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586352 STORZ ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI NURSE ASSIST, LLC. 26006MD VQ01

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female