BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 15427313 · Received September 15, 2022

    Report

    Report Number
    15427313
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    July 25, 2022
    Report Date
    August 12, 2022
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DR. WENT TO USE THE STAPLER AND IT SUCCESSFULLY FIRED FOR ITS FIRST USE. A RELOAD WAS LOADED FOR SECOND TIME USE, BUT THE INSTRUMENT MISFIRED AND DID NOT WANT TO UNLOCK. DR. WAS ABLE TO REMOVE IT FROM THE PATIENT AND PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250576 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75DA0611

    Patients

    Seq Age Sex Outcome Treatment
    1 1460 DA Female