BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 16894341 · Received May 9, 2023

    Report

    Report Number
    16894341
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 1, 2023
    Manufacturer
    BOLDER SURGICAL, LLC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE SURGEON - "THE DEVICE DID NOT WORK PROPERLY, DID NOT CUT AS IT SUPPOSED TO DO. THE SAME DEVICE FAILED TO WORK IN THE SIMILAR CASE." THE DEVICE WAS PACKED IN THE PLASTIC BAG WITH COVER AND GIVEN TO BUSINESS OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639280 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GAG BOLDER SURGICAL, LLC JR-ST25-2.0 75FB7789

    Patients

    Seq Age Sex Outcome Treatment
    1 Male