BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 8365853 · Received February 25, 2019

    Report

    Report Number
    8365853
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    December 5, 2018
    Report Date
    December 10, 2018
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GAG
    UDI-DI
    00865163000102
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A DISPOSABLE LAPAROSCOPIC STAPLER WAS OPENED FOR PATIENT'S THORASCOPIC LUNG SURGERY. THE STAPLER LOAD THAT CAME WITH THE STAPLER FAILED TO FIRE ANY STAPLES. NO HARM CAME FROM THE ATTEMPT OF USE. ANOTHER STAPLER LOAD WAS OPENED AND USED WITH THE ORIGINALLY OPENED STAPLER HANDPIECE WITHOUT ISSUE. MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, JUST RIGHT 5 MM STAPLER (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159877 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75DH0900 00865163000102

    Patients

    Seq Age Sex Outcome Treatment
    1 150 DA