BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 7406334 · Received April 9, 2018

    Report

    Report Number
    7406334
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 3, 2018
    Report Date
    April 2, 2018
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A ENDOSCOPIC SURGICAL PROCEDURE WHILE DEPLOYING A 5MM STAPLER THE SURGEON STATED THAT THE 5MM STAPLER RELOAD CARTRIDGE MISFIRED. RELOAD REMOVED AND NEW RELOAD INSERTED AND STAPLER FIRED NORMALLY. RELOAD SEQUESTERED AND SENT TO BIOMEDICAL FOR REPORTING. PACKAGING SAVE TO GIVER TO MANUFACTURER FOR ANALYSIS. CASE PROCEEDED WITHOUT FURTHER INCIDENT. MANUFACTURER RESPONSE FOR STAPLER, 5MM SURGICAL, JUSTRIGHT (PER SITE REPORTER): AWAITING FOLLOW UP WITH MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250280 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75IG1818

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR 5MM STAPLER HANDPIECE