BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLER

    MDR report key: 10546361 · Received September 16, 2020

    Report

    Report Number
    MW5096704
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 14, 2020
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STAPLER MALFUNCTION WOULD NOT FIRE-RELOAD OPENED, LOADED THEN WORKED; 5 MM STAPLER (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003771 STAPLER STAPLE, IMPLANTABLE GDW JUSTRIGHT SURGICAL, LLC 00865163000102 75LI1801

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA