BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 19247203 · Received May 6, 2024

    Report

    Report Number
    19247203
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 10, 2024
    Report Date
    April 30, 2024
    Manufacturer
    BOLDER SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    5MM JUST RIGHT STAPLER MISFIRED DURING PROCEDURE. SOME STAPLES FIRED BUT NOT A COMPLETE LINE, AND THE BLADE DID NOT CUT AT ALL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661530 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG BOLDER SURGICAL, LLC JR-ST25-2.0 75HC5678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown