BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 11320926 · Received February 12, 2021

    Report

    Report Number
    11320926
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 14, 2021
    Report Date
    January 18, 2021
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USED STAPLER, BUT STAPLE LINE HAD BLEEDING, CONCERNING FOR INCOMPLETE OCCLUSION. SURGEON FEELS THE STAPLER MALFUNCTIONED. MANUFACTURER RESPONSE FOR JUST RIGHT 5MM SURGICAL STAPLER, JUST RIGHT SURGICAL (PER SITE REPORTER). UNKNOWN, OR MATERIALS MANAGER CONTACTED REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217207 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75IJ1734

    Patients

    Seq Age Sex Outcome Treatment
    1 5110 DA