BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 13358151 · Received January 26, 2022

    Report

    Report Number
    13358151
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Date of Event
    January 14, 2022
    Report Date
    January 21, 2022
    Manufacturer
    JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    5MM JUST RIGHT STAPLER USED TO RESECT RIGHT LUNG. STAPLER MISFIRED AND WAS UNABLE TO BE PULLED OUT THROUGH 5MM TROCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701976 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL 75KJ0204

    Patients

    Seq Age Sex Outcome Treatment
    1 300 DA Female