BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 9915893 · Received April 2, 2020

    Report

    Report Number
    9915893
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 10, 2020
    Report Date
    March 23, 2020
    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

    STAPLER FIRED AND IT DID NOT CLOSE COMPLETELY ON THE APPENDIX. THE STAPLER ALSO DID NOT OPEN CORRECTLY MAKING IT HARD TO REMOVE THE STAPLER FROM THE PATIENT. ALL STAPLES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378985 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75K10506

    Patients

    Seq Age Sex Outcome Treatment
    1