BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 10074248 · Received May 20, 2020

    Report

    Report Number
    10074248
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 18, 2020
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A LAPAROSCOPIC PROCEDURE FOR THE PLACEMENT OF A GASTROSTOMY TUBE. THE SURGICAL STAPLER MISFIRED WHEN USED DURING THE PROCEDURE. A DIFFERENT DEVICE WAS NEEDED TO CONTINUE THE SURGICAL PROCEDURE. THE PATIENT HAD TO HAVE THE SIZE OF ONE OF THE LAPAROSCOPIC PORTS UPSIZED TO ACCOMMODATE THE DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539836 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75II1854

    Patients

    Seq Age Sex Outcome Treatment
    1 5475 DA