BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT

    MDR report key: 5254028 · Received November 30, 2015

    Report

    Report Number
    5254028
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 30, 2015
    Manufacturer
    JUSTRIGHT SURGICAL LLC
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A "JUSTRIGHT" ENDOSCOPIC STAPLER (5MM W/25MM LOAD) WAS OPENED AND LOADED BY THE SURGICAL TECH, AND USED APPROPRIATELY BY THE SURGICAL RESIDENT UNDER SUPERVISION OF THE ATTENDING PHYSICIAN. THE FIRST LOAD FIRED PROPERLY. A SECOND LOAD WAS NEEDED, AND WAS OPENED, BUT WOULD NOT PROPERLY LOAD INTO THE STAPLER, THE LOAD WOULD NOT "CLICK" FIRMLY INTO PLACE. SEVERAL ATTEMPTS WERE MADE. A SECOND JUSTRIGHT STAPLER WAS OPENED AND FIRED CORRECTLY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785741 JUSTRIGHT STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR